A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Phase: NA
Conditions: Pancreas Cancer
Sponsor: Cedars-Sinai Medical Center

 
CONFIDENTIAL  
This material is the property of Cedars-Sinai Medical Center. Do not disclose or use except as authorized in writing by the study 
sponsor. 
 
 
 
IIT2021-18-CHANG-PREHAB  
 
A Supervised Prehabilitation Program for 
Patients with Pancreatic Cancer 
 
 
Principal Investigator:  
Philip Chang, DO 
 
 
 
 
Cedars-Sinai Medical Center 
 
 
 
 
8700 Beverly Blvd, Los Angeles, CA 90048 
 
 
 
 
310- 467- 4498 
 
 
 
 
Philip.Chang@cshs.org 
 
  
Sub-Investigator(s) 
Department/Division 
Arash Asher, MD 
Department of Physical Medicine and Rehabilitation 
Andrew Hendifar, MD  
Department of Medical Oncology 
Gillian Gresham, PhD 
Cancer Research Center for Health Equity 
Alix Sleight Warner, PhD 
Department of Physical Medicine and Rehabilitation 
Jun Gong, MD 
Department of Medical Oncology 
Arsen Osipov, MD 
Department of Medical Oncology 
Kamya Sankar, MD 
Department of Medical Oncology 
Jeremy Lorber, MD 
Department of Medical Oncology 
David Hoffman, MD 
Department of Medical Oncology 
Kevin Scher, MD 
Department of Medical Oncology 
 
 
 
 
Biostatistician: 
Shaowli Kabir, PhD 
 
Funding Source:  
Cedars-Sinai Medical Center (CSMC) 
 
ClincialTrials.gov Reg:  
Not Required 
 
NCT Number:   
 
NCT05692323 
 
ClincialTrials.gov Reporting: Not Required 
 
Current Version: 
 
Protocol Version #4 Dated 23JAN2025 
 
Initial version:  
 
Protocol Version #1 Dated 23MARCH2023 
 
 
 
 

 
CONFIDENTIAL  
This material is the property of Cedars-Sinai Medical Center. Do not disclose or use except as authorized in writing by the study 
sponsor. 
 
IIT2021-18-CHANG-PREHAB 
 
Protocol Version #4: 23JAN2025 
 
 
Signature Page 
 
 
The signature below constitutes the approval of this protocol and the attachments and provides the 
necessary assurances that this trial will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory requirements 
and applicable U.S. federal regulations and ICH guidelines. 
 
 
 
 
______________________________________________ 
 
 
_________________ 
Principal Investigator (PI) Signature    
 
 
 
 
Date 
 
 

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TABLE OF CONTENTS  
LIST OF ABBREVIATIONS............................................................................................................. 1 
STUDY SCHEMA ............................................................................................................................ 2 
STUDY SUMMARY ......................................................................................................................... 3 
1.0 
BACKGROUND AND RATIONALE ................................................................................... 4 
2.0 
STUDY OBJECTIVES ........................................................................................................ 5 
3.0 
STUDY DESIGN ................................................................................................................. 6 
4.0 
PATIENT ELIGIBILITY ....................................................................................................... 7 
5.0 
INTERVENTION PLAN ....................................................................................................... 8 
6.0 
STUDY PROCEDURES...................................................................................................... 9 
7.0 
UNANTICIPATED PROBLEMS INVOLVING RISK TO SUBJECTS OR OTHERS (UPIRSO)
 
15 
8.0 
STATISTICAL CONSIDERATIONS ................................................................................. 17 
9.0 
STUDY MANAGEMENT ................................................................................................... 17 
10.0 
REFERENCES .................................................................................................................. 23 
11.0 
APPENDIX ........................................................................................................................ 24 

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LIST OF ABBREVIATIONS 
 
BMI 
Body Mass Index 
CRF 
Case Report Forms 
CCTO 
Cancer Clinical Trials Office 
CT 
Computed Tomography 
U.S CSMC 
Cedars-Sinai Medical Center 
DSMC 
Data and Safety Monitoring Committee 
FDA 
U.S Food and Drug Administration 
GCP 
Good Clinical Practice  
IRB 
Institutional Review Board 
PAR-Q 
Physical Activity Readiness Questionnaire 
PI 
Principal Investigator 
PREHAB 
Prehabilitation 
PROMIS-29 
Patient-Reported Outcomes Measurement Information System 
PROMIS Cancer Function 
Patient-Reported Outcomes Measurement Information System Cancer Function 
QMC 
Quality Management Core 
SOC 
Standard of Care 
SOCCI 
Samuel Oschin Comprehensive Cancer Institute  
UPIRSO 
Unanticipated Problems Involving Risk to Subjects or Others 
 
 
                   

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STUDY SCHEMA  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PREHAB- Prehabilitation 
Primary endpoint: Feasibility of a PREHAB program evaluated by attendance. The program will 
be considered feasible if at least 50% of participants attend at least 60% of exercise sessions.  
Screening and Enrollment 
Baseline Evaluation 
Supervised PREHAB Sessions  
(6 weeks) 
Post-Intervention Evaluation 
3-Month Follow Up 

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STUDY SUMMARY 
Title 
A Supervised Prehabilitation Exercise Program for Patients with Pancreatic 
Cancer 
Short Title 
Exercise program for pancreatic cancer 
Protocol Number 
IIT2021-18-CHANG-PREHAB 
Phase 
Pilot 
Methodology 
Single Arm 
Study Duration 
12 Months 
Study Center(s) 
Single Center 
Objectives 
The primary objective is to test the feasibility of a supervised prehabilitation 
program for patients with pancreatic cancer.  
Number of Subjects 
16 subjects 
Diagnosis and Main 
Inclusion Criteria 
Main Inclusion Criteria: 
-Pancreatic cancer diagnosis (any stage)  
-Age ≥18 years  
-Independent ambulation and activities of daily living  
-Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23 
-Physically able to participate in study assessments 
-Answers no to all questions on PAR-Q OR is cleared to participate by the 
study physician  
-Written informed consent obtained from subject and ability for subjects to 
comply with the requirements of the study 
Study Product(s), Dose, 
Route, Regimen 
Supervised exercise PREHAB program  
Duration of administration 
6 weeks  
Reference therapy 
None 
Statistical Methodology 
The primary analysis will test the hypothesis of feasibility using an one-sided 
exact Binomial test at 25% significance level. If 10 or more patients attend a 
minimum of 60% of exercise sessions during the initial 6-week period, then 
the study will be declared feasible. 
 
 
 
 
 
 
 
 
 
 

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1.0 
BACKGROUND AND RATIONALE 
1.1 
Disease Background 
During 2022, there is estimated to be 62,000 new cases of pancreatic cancer, causing an 
estimated 49,000 deaths1. Individuals who develop pancreatic cancer tend to be older, 
with 70% of pancreatic diagnoses occurring in those ≥ 65 years2. As individuals age their 
risk of comorbidities such as sarcopenia and frailty increase3. Sarcopenia is the 
progressive loss of skeletal muscle mass, tone, quality and strength and has been 
reported to affect 65% of pancreatic cancer patients4. Results from a recent meta-
analysis suggest sarcopenia is associated with decreased long-term survival and is an 
important prognostic factor in recurrent pancreatic cancer4,5.  
 
1.2 
Study Background  
1.2.1 
Prehabilitation (PREHAB)  
PREHAB is the process of improving the functional capability and psychological health of 
the individual to reduce the incidence and/or severity of future impairments6. While 
PREHAB has most commonly been described as occurring prior to neoadjuvant therapy 
and surgery it can also occur in nonsurgical patients and concurrently with neoadjuvant 
treatment6,7. The foundation of PREHAB is functional exercise yet can be multimodal in 
nature and can include additional components such as nutritional support, smoking 
cessation, and stress reduction9. PREHAB sessions are typically delivered through 
structured programs and have been shown to have a number of benefits such as 
improvements in functional activity and decreased postoperative complications8. 
1.2.2 
Clinical Data 
Multiple studies have reported the positive effects of PREHAB in cancer patients9. A 
recent systematic review reported improved functional activity and survival outcomes in a 
range of cancer types following moderate to vigorous intensity exercise participation18. In 
colorectal cancer patients, PREHAB programs have shown to improve VO2 max and 
functional activity (6 minute walk tests)10,11. In patients undergoing cystectomy, PREHAB 
has been shown to increase power output and performance with activities of daily living12. 
A recent review by Garcia et al, reported improved pulmonary function, less days spent in 
the hospital and reduced risk of postoperative complications in lung cancer patients 
following participation in a PREHAB program13. An additional Cochrane review of 167 
patients with non-small cell lung cancer reported preoperative exercise training may 
reduce postoperative pulmonary complications, decrease postoperative hospital lengths 
of stay, and improved exercise capacity14. In a study by Ngo-Huang et al, 50 pancreatic 
cancer participants participated in a home-based multimodal program including at least 
60 minutes moderate intensity aerobic exercise weekly and at least 60 minutes full body 
strengthening exercises weekly. The mean duration of the exercise program was 16 
weeks and patients were found to have improved physical function and health related 
quality of life15.  
 
There is currently inconsistency surrounding PREHAB delivery method and use of 
additional nutritional dietary supplementation.  In a recent systematic review of pancreatic 
cancer PREHAB studies (n=6) there was considerable variation seen in; when to initiate 
PREHAB, exercise programming duration, supervision of sessions, exercise types, 
dietary supplementation, and reporting of outcomes8. Favorable outcomes were reported 
in studies which started PREHAB prior to surgery, were ≥ 6-week in duration, included 
supervised sessions and included moderate intensity aerobic training combined with 
resistance training. 

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1.3 
Rationale 
PREHAB has previously been reported to significantly improve quality of life, physical 
function and decreased post-operative complications in several cancer populations. 
Given the positive benefits reported in both physical function and quality of life post 
participating in PREHAB sessions the purpose of this study is to demonstrate the 
feasibility of a multimodal supervised PREHAB program in pancreatic cancer patients. 
Secondary aims include assessing safety and exploring benefits in sarcopenia, quality of 
life and functional performance.  
 
2.0 
STUDY OBJECTIVES  
2.1 
Primary Objective 
2.1.1 
To assess the feasibility of a 6-week supervised PREHAB program for pancreatic 
cancer patients 
2.2 
Secondary Objective  
2.2.1 
To evaluate the safety of a 6-week supervised PREHAB program for pancreatic 
cancer patients  
2.3 
Exploratory Objectives 
2.3.1 
To assess the impact of a PREHAB program on sarcopenia  
2.3.2 
To assess the impact of a PREHAB program on health-related quality of life 
including domains of physical function, fatigue, and social participation 
2.3.3 
To assess the impact of a PREHAB program on functional performance including 
strength and endurance 
2.3.4 
To assess the association between a PREHAB program and healthcare 
utilization including number of hospitalizations and length of stay 
2.3.5 
To assess the impact of a PREHAB program on post-operative outcomes 
including length of stay and complication rates  
2.3.6 
To assess the impact of a PREHAB program on continuous activity and sleep 
patterns  
2.3.7 
To assess the impact of a validated, web-based, health self-management guide 
designed for individuals with chronic illnesses (www.painguide.com)  
 
 
2.3.8 
To assess the impact of a PREHAB program on weight and BMI 
 
2.4 
Endpoints 
2.4.1 
Primary Efficacy Endpoint 
 
Feasibility – REHAB session feasibility is defined as at least 10 of the 16 
participants attending at least 60% of scheduled sessions   

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2.4.2 
Secondary Efficacy Endpoint 
 
Safety - PREHAB program safety will be evaluated by monitoring unanticipated 
problems involving risk to subjects or others (UPIRSO). At each PREHAB 
session, the post intervention evaluation and the 3 month follow up visit the 
exercise physiologist or personal trainer will record any side effects or symptoms 
reported by the subject. Within a week the treating physician or Principal 
Investigator (PI) will review and classify all events. Any events meeting the 
definition of a UPIRSO will be documented on the UPIRSO log and/or to the IRB 
by the coordinator within 10 business days.   
 
2.4.3 
Exploratory Endpoints 
 
 
 
2.4.3.1   Impact on sarcopenia we will be measured using changes in hand grip 
strength and the short physical performance battery measured at Baseline, Post-
Intervention Evaluation and 3-month Follow Up. Changes in Muscle Mass 
measured at Baseline and 3-month Follow Up will also be utilized. 
 
 
 
2.4.3.2  Health-related quality of life will be measured by changes in the 
PROMIS-29 and PROMIS Cancer Function 3D Profile16 scores measured at 
Baseline, Post-Intervention Evaluation and 3-month Follow Up. 
 
 
2.4.3.3  Functional Performance will be measured by changes in the 6-minute 
walk test and physical performance metrics scores measured at Baseline, Post-
Intervention Evaluation and 3-month Follow Up. 
 
 
2.4.3.4  Hospitalizations and length of stay  will be recorded from medical 
record review and a telephone follow-up with the patient and their caregivers at 
the 3-month follow up. Only hospitalizations post Baseline will be recorded.     
 
 
 
2.4.3.5  Post-operative outcomes will be recorded from medical record review 
and a telephone follow-up with the patient and their caregivers at the 3-month 
follow up. Only operations post Baseline will be recorded. Post-operative 
complications will be assessed by the investigator retrospectively using the 
Clavien-Dindo classification system17,18. 
 
 
2.4.3.6 Physical Activity and Sleep will be measured by continuous activity and 
sleep monitoring by the Fitbit wrist worn device. The Fitbit will be worn from 
Baseline through to the 3-month Follow Up.  
 
 
2.4.3.7 Impact of the online Pain guide will be measured by the Patient Global 
Impression questionnaire administered at the Post Intervention Evaluation Visit.  
 
 
2.4.3.8 Impact on weight and BMI will be measured using changes in weight and 
BMI measured at Baseline, Post-Intervention Evaluation and 3-month Follow Up.  
 
 
3.0 
STUDY DESIGN 
This is single site, pilot study designed to test the feasibility of a 6-week PREHAB 
program in pancreatic patients. All patients will participate in a 6-week supervised 
PREHAB program with either an exercise physiologist or personal trainer. Each week, 
patients will undergo 3 x 1 hour supervised training sessions consisting of moderate 
intensity aerobic training and resistance training. In addition to the supervised sessions, 

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patients will be instructed to accumulate a total of 150 minutes per week of moderate 
aerobic training at home. 
This study has been designed to assess the hypothesis that a supervised PREHAB 
program is feasible in pancreatic cancer patients.  
 
 
 
3.1 
Inclusion of Women and Underrepresented Minorities  
The total number of subjects involved in the study will be 16. Of those, we estimate that 
approximately 20% will be cisgender women. The estimated racial/ethnic breakdown of 
the study may approximately be that 15% may be Black or African American, 5% may be 
Asian, and 1% may be Native Hawaiian-Pacific Islander. Approximately 15% of the 
subjects may be Hispanic. While this provides only an estimated breakdown of the study 
population, efforts should be made to ensure equitable recruitment of individuals that 
meet the above eligibility requirements.  
 
 
4.0 
PATIENT ELIGIBILITY  
4.1 
Inclusion Criteria  
4.1.1 
Pancreatic cancer diagnosis (any stage)  
4.1.2 
Age ≥ 18 years  
4.1.3 
Independent ambulation and activities of daily living (Discretion of referring/ 
treating oncologist)  
4.1.4 
Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23 
4.1.5 
Physically able to complete functional assessments including 6-minute walk test, 
hand grip strength, short performance physical battery and performance metrics 
4.1.6 
Answers no to all questions on PAR-Q OR is cleared to participate by their 
treating oncologist  
4.1.7 
Written informed consent obtained from subject and ability for subjects to comply 
with the requirements of the study 
 
Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain 
portal only (failure to meet inclusion criterion 4.1.9 should not preclude subjects 
from participating in main study): 
 
4.1.8 
Access to a smart device capable of Fitbit syncing and accessing the online Pain 
portal (www.painguide.com) 
 
4.2 
Exclusion Criteria 
4.2.1 
Current pregnancy 
 

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Exclusion criteria for remote monitoring component of the study with Fitbit only 
(failure to meet exclusion criterion 4.2.3 should not preclude the subject from 
participating in main study): 
4.2.2 
Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear 
implants (removable hearing aids permitted), or other electronic medical 
equipment, unless the treating physician deems study participation safe.  
 
5.0 
INTERVENTION PLAN 
This is a multimodal PREHAB program with the following elements: 
 
  
5.1 
PREHAB Components  
5.1.1 
Functional Exercise  
Participants will attend 3 x weekly 1hr in-person supervised exercise sessions 
with a trained exercise physiologist or personal trainer for a 6-week period. 
Sessions will be scheduled around the participants and the trainer’s availability.  
Sessions will be held in the hospital gym at Cedars-Sinai – 250N Robertson, 
Blvd, Beverly Hills. During these sessions patients will undergo aerobic and 
resistance training. 
 
Missed Sessions: Patients will be strongly advised not to miss any sessions. 
Sessions missed due to cancellations from the study team or participant (due to 
sickness, holidays, etc.) will be made during an optional 7th week following the 6-
week intervention. There will be up to three make-up sessions. Patients will not 
be required to attend these make-up sessions but if they do not attend it will 
count as a missed session.  
5.1.2 
Nutrition 
If patients have not previously been referred to a hospital dietitian during their 
pancreatic cancer care, they will receive a referral prior to their first PREHAB 
session.  
5.1.3 
Self- Management 
Participants will be provided with a wrist worn Fitbit device to wear continuously 
from the Baseline visit through to the 3 Month Follow Up Visit. The Fitbit will 
monitor daily physical activity, sleep, and heart rate. 
 
Patients will be instructed to accumulate a total of 150 minutes per week of 
moderate aerobic training at home outside of the set sessions. This will be 
measured by Fitbit data. It is not a deviation if they do not complete this many 
minutes per week.  
 
All patients will be given the option to access an online pain management portal. 
This website (www.painguide.com) from the University of Michigan provides 
information on the management and monitoring of symptoms and behaviors 
including sleep and physical activity. Participants will be provided training on how 
to use and interact with this online portal.  Use of this platform is optional; 
however, participants will be encouraged to engage with the portal at least once 
weekly. Portal use will be assessed via self-report every two weeks.   
 
Following completion of the 6-week intervention, patients will be given resistance 
bands to continue with resistance training at home. At home exercise following 

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the 6-week intervention is at the participants own discretion and will be monitored 
by Fitbit data.  
5.1.4 
Muscle Mass calculation 
The SOC Abdomen CT scans will be reviewed for muscle mass. CT images will 
be analyzed via Analyze 14.0 software by the Cedars-Sinai Imaging Core or 
trained personal. 
 
5.2 
PREHAB intensity / injury 
Patients will participate in specific PREHAB exercises as they are able. Aerobic activity 
will be adjusted per participant to a level of 4-6 on a modified Borg Scale. Level of 
resistance for each exercise will be adjusted by the exercise trainer/physiologist such that 
repetitions are being performed at ~75% of the one repetition maximum. Chest specific 
exercises including chest press, dips, and push-ups will be omitted for patients with ports.  
Any patients experiencing symptoms of dizziness, lightheadedness or dyspnea will be 
instructed to take a break until symptoms resolve. Patients with unresolving symptoms or 
more serious symptoms like chest pain will be referred to the cancer rehabilitation 
physician who will evaluate the patient and refer to acute services as indicated.  
Patients who sustain injuries related to the PREHAB sessions may remain on the study 
as long as their injury does not prevent them from completing the exercise protocol.  
5.3 
Standard of Care (SOC) Procedures 
As SOC, patients will undergo Computed Tomography (CT) scans periodically throughout 
their pancreatic cancer diagnosis and treatment. This study will review SOC Abdomen 
CT scans undertaken closest to both the Baseline and 3 month follow up visit.  
Patients will also undergo SOC labs periodically throughout their pancreatic cancer 
diagnosis and treatment. This study will review SOC labs undertaken closest to each 
PREHAB session to determine safe physical activity participation.  
5.4 
Duration of Study Participation  
The study duration per subject will be approximately 23 weeks, with up to 4 weeks of 
screening, up to 7 weeks on treatment, and 3 months of follow-up.  
5.5 
Removal of Patients from Protocol  
Patients will be removed from the study when any of the criteria listed in Section 6.6 
apply. If any of these criteria are met the PI will be notified and the reason for study 
removal and the date the patient was removed will be recorded. The patient should be 
followed-up per protocol. 
5.6 
Subject Replacement  
Subjects who withdraw from the study prior to their PREHAB session 1 will be replaced.   
Subjects who attend at least the first session will be evaluable for both the primary and 
secondary endpoint analysis. To be evaluable for exploratory endpoints subjects will 
need to complete the 3 month follow up visit.  
 
6.0 
STUDY PROCEDURES 

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6.1 
Screening Procedures (Within 28 days of Baseline) 
Assessments performed exclusively to determine eligibility for this study will be done only 
after obtaining informed consent. Assessments performed for clinical indications (not 
exclusively to determine study eligibility) may be used for baseline values even if the 
studies were done before informed consent was obtained.  
 
All screening procedures must be performed within 28 days prior to registration unless 
otherwise stated. The screening procedures include: 
6.1.1 Informed Consent 
Informed consent will be obtained in accordance with the Institutional Review 
Board (IRB) policies and procedures as described in the IRB application. For non-
English speaking patients, an interpreter will be used.  
6.1.2 Medical history  
Relevant medical history, including history of current disease and information 
regarding underlying diseases (Medical record review) 
6.1.3 Demographics 
 
 
Age, gender, race, ethnicity 
 
 Patients may be offered the Inclusive Demographics Questionnaire, which is a 
standard, non-study-specific document, available on the IRB Intranet. Study team 
to record responses in the subject’s OnCore record. Completion is voluntary; 
patients may decline to complete the Inclusive Demographics Questionnaire. 
6.1.4 Pregnancy status 
Pregnancy status will be confirmed with patient and via medical record review.  
6.1.5 Godin-Shephard Leisure-Time Physical Activity Questionnaire 
For non-English speaking patients, an interpreter will be used for the 
questionnaire. 
6.1.6 Physical Activity Readiness Questionnaire (PAR-Q)  
Patients who answer no to all questions on the PAR-Q will not require physician 
clearance. Any patients who answer yes to a question may be cleared by either a) 
their treating/referring oncologist or b) one of the study physicians following an in-
person visit or phone call with chart review.  
 
For non-English speaking patients, an interpreter will be used for the 
questionnaire. 
6.1.7 Physical Activity assessment 
Ambulatory status, ability to complete functional assessments including 6-minute 
walk test, hand grip strength, short performance physical battery and performance 
metrics.  
6.1.8 Review subject eligibility criteria 
 
6.2 
Baseline Procedures (within 14 days of first PREHAB session) 
All baseline procedures will occur after the patient is deemed to be eligible by review of 
the eligibility criteria.  

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6.2.1 
Physical Evaluation 
• 
Vitals (Height, Weight, Body Mass Index (BMI)) 
• 
Six-minute walk test 
• 
Hand grip strength 
• 
Physical performance metrics 
o 
Strength is measured in reps within 60 seconds of leg press, bicep 
curls, heel raises, plank holds and lateral pull downs.  
o 
Functional testing includes the sit to stand test.  
o 
Balance testing includes static standing balance with the eyes open 
and closed on firm and foam surfaces. Balance is rated as poor, fair, 
good, or excellent.  
• 
Short performance physical battery 
6.2.2 Questionnaires 
• 
Patient-Reported Outcomes Measurement Information System (PROMIS-29)  
• 
Patient-Reported Outcomes Measurement Information System Cancer 
Function (PROMIS Cancer 3D Function) 
 
For non-English speaking patients, an interpreter will be used for the 
questionnaires. 
6.2.3 SOC Abdomen CT scan  
• 
Document date of closest SOC Abdomen CT scan (ok if occurred prior to 
consent or greater than 14 days prior to first PREHAB session) 
6.2.4 Review of SOC Lab Results 
• 
Participants are anticipated to be undergoing neoadjuvant therapies 
concurrently with study participation. These therapies may impact the 
participants circulating cytokines, thus rendering them ineligible to participate 
in physical activity.  
Prior to each PREHAB session exercise physiologist or personal trainer will 
check the participants’ medical records for the most recent SOC lab results. 
To participate all 3 thresholds must be met:  
• absolute neutrophils >0.5 1000/UL 
• platelets > 50 1000/UL 
• hemoglobin >8 g/dl  
If one or more of these thresholds are not met the PI will be notified and the 
participant will be unable to participate in the exercise session. Sessions will 
resume when all lab values have reached the required thresholds or at the 
PI’s discretion. 
These thresholds were determined by the cancer rehabilitation physiatrists 
and referring pancreatic oncologists and are in line with other cancer activity 
recommendations19,20. 
6.2.5 Fitbit Training and Use 
• 
Training will include how to wear, charge and sync Fitbit 
• 
Participants will start wearing the Fitbit continuously from the Baseline 
session 
• 
Subjects who are unable to meet eligibility criteria 4.1.9 or who do meet 
exclusion criteria 4.2.3 will be exempt from this study task.   

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6.2.6 Dietitian Referral  
• 
Patients not previously referred to a hospital dietitian during their pancreatic 
cancer care will be referred 
6.2.7 Online Pain Portal Training (first 8 participants only) 
• 
Training will include how to use and interact with the validated online portal 
(www.painguide.com) created by the University of Michigan. The exercise 
physiologist/personal trainer staff will follow up with patients weekly to 
biweekly to record usage of the portal.   
• 
Subjects who are unable to meet eligibility criteria 4.1.9 will be exempt from 
this study task.   
6.3 
Study Procedures  
6.3.1  Week 1 – Week 6* (Within 14 days of Baseline) 
• 
3 x weekly 1 hour PREHAB session 
• 
Continuous activity monitoring (Fitbit)  
• 
Unanticipated Problem review  
• 
Optional use of the Online Pain Portal. Self-Report portal interaction. 
• 
SOC Lab review – If labs do not meet criteria in Section 6.2.4, STOP and 
call the PI 
• 
150 minutes of self-managed exercise per week at home (measured by Fitbit 
data) 
 
*Up to 3 missed sessions will be made up in a 7th week 
6.3.2  Post-Intervention Evaluation (Within 14 days following the last PREHAB 
session) 
Can be on the same day as the last PREHAB session 
• 
Vitals (Weight, BMI) 
• 
Six-minute walk test 
• 
Hand grip strength 
• 
Physical performance metrics 
• 
Short performance physical battery 
• 
Unanticipated Problem review 
• 
PROMIS-29 (for non-English speaking patients, an interpreter will be used 
for the questionnaire) 
• 
PROMIS Cancer 3D Function Profile (for non-English speaking patients, an 
interpreter will be used for the questionnaire) 
• 
Patient Global Impression of Change (Only those participants who used the 
Online Pain portal) 
• 
Continuous activity monitoring (Fitbit)  
6.4 
Follow-up Procedures - Three Month Follow-Up (± 14 days) 
6.4.1 
Physical Evaluation  
• 
Vitals (Weight, BMI) 
• 
Six-minute walk test 
• 
Hand grip strength 
• 
Physical performance metrics 
• 
Short performance physical battery 
• 
Unanticipated Problem review 
• 
Last day of Fitbit Use  

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6.4.2 Questionnaires 
• 
PROMIS-29 
• 
PROMIS Cancer 3D Function Profile 
 
For non-English speaking patients, an interpreter will be used for the 
questionnaires. 
6.4.3 SOC Abdomen CT scan 
• 
Document date of closest SOC Abdomen CT scan (ok if occurs outside of 
the 3 month ± 14 days window)  
6.4.4 Healthcare Utilization Assessment (May be assessed by chart review, in-
person discussion at visit and/or phone call) 
o 
Number of hospitalizations 
o 
Reason for hospitalization 
o 
Days hospitalized 
o 
Disposition: continued therapy, hospice, death, other 
o 
If underwent resection then evaluate post-op complications - Post-
operative complications will be assessed using the Clavien-Dindo 
classification system17,18 

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6.5 
Time and Events Table  
 
 
 
Screening 
(Within 28 
days of 
Baseline) 
Baseline 
(Within 14 days 
of first PREHAB 
session) 
Week 1 
– Week 
61 
Post-Intervention 
Evaluation 
(Within 14 days of last 
PREHAB session) 
3 Month 
Follow-
Up 
(± 14 
days) 
Informed Consent 
X 
 
 
 
 
Confirm Eligibility 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Pregnancy status2 
X 
 
 
 
 
Godin Leisure-Time 
Exercise Questionnaire 
X 
 
 
 
 
PAR-Q 
X 
 
 
 
 
Physical Activity 
Assessment 
X 
 
 
 
 
Vitals (Height, Weight, 
BMI)3 
 
X 
 
X 
X 
Six Minute Walk Test 
 
X 
 
X 
X 
Hand Grip Strength 
 
X 
 
X 
X 
Physical Performance 
Metrics 
 
X 
 
X 
X 
Short Performance Physical 
Battery 
 
X 
 
X 
X 
Unanticipated Problem 
review 
 
 
X 
X 
X 
PROMIS-29 
 
X 
 
X 
X 
PROMIS Cancer 3D 
Function Profile 
 
X 
 
X 
X 
SOC Abdomen CT Scan4 
 
X 
 
 
X 
SOC Lab Test Review 
 
X 
X5 
 
 
Fitbit activity monitoring6 
 
X 
X 
X 
X 
Dietitian referral7 
 
X 
 
 
 
Online Pain platform8 
Training 
 
X 
 
 
 
Online Pain platform use8 
 
 
X 
 
 
Online Pain platform 
compliance 
 
 
X9 
 
 
3 x Weekly 1HR PREHAB 
session 
 
 
X 
 
 
Patient Global Impression 
of Change10 
 
 
 
X 
 
Healthcare Utilization 
Assessment 
 
 
 
 
X 
 
BMI: Body Mass Index, CT: Computed Tomography, PAR-Q: Physical Activity Readiness Questionnaire 
1. Up to 3 missed sessions will be made up in a 7th week 
2. Pregnancy status confirmed with patient and via medical record review  

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3. Height will only be collected at Baseline 
4. CT scans completed closest to baseline and 3-month follow-up will be used, even if they 
occurred outside of the relevant visit window.  
5. SOC labs will be reviewed prior to each PREHAB session 
6. Fitbit use is only required by those who met eligibility criteria 4.1.9 and do not meet exclusion 
criteria 4.2.3. 
7. Only patients not previously referred to a Dietitian will be referred by the study team 
8. Online Pain platform training and use is only required for those who met eligibility criteria 
4.1.9 (First 8 participants only) 
9. Online Pain platform compliance will be self-reported every 2 weeks (First 8 participants only) 
10. Only completed by the participants who used the Online Pain Portal 
 
6.6 
Removal of Subjects from Study 
Patients can be taken off the study intervention and/or study at any time at their own 
request, or they may be withdrawn at the discretion of the investigator for safety, 
behavioral or administrative reasons. The reason(s) for discontinuation will be 
documented and may include: 
6.6.1 
Patient voluntarily withdraws (follow-up permitted);  
6.6.2 
Patient withdraws consent (termination of treatment and follow-up); 
6.6.3 
Patient is unable to comply with protocol requirements; 
6.6.4 
Treating physician determines continuation on the study would not be in the 
patient’s best interest; 
6.6.5 
Patient becomes pregnant (pregnancy to be reported along same timelines as a 
serious adverse event); 
6.6.6 
Lost to follow-up. If a research subject cannot be located to attend their 3-month 
follow up session subject may be considered “lost to follow-up.” All attempts to 
contact the subject during the 3 months must be documented.  
6.6.7 
Patient displays aggression or hostility towards study staff.  
 
7.0 
UNANTICIPATED PROBLEMS INVOLVING RISK TO SUBJECTS OR OTHERS (UPIRSO) 
7.1 
 UPIRSO Collection and Reporting  
As this trial intervention and the corresponding research procedures pose no known risk 
to subjects, unexpected/unanticipated problems will be reported in place of Adverse 
Event reporting. Treating investigator or PI will evaluate patients through medical record 
review or patient visit from PREHAB session 1 through to the 3 Month Follow-Up visit for 
any unanticipated problems.  
7.1.1 
Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) 
Unanticipated problems include any incident, experience, or outcome that meets 
all of the following criteria: 
• 
Unexpected (in terms of nature, severity, frequency) given (a) the 
research procedures that are described in the protocol-related 
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research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• 
Related or possibly related to participation in the research (possibly 
related means there is a reasonable possibility that the incident, 
experience, or outcome may have been caused by the procedures 
involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of 
harm (including physical, psychological, economic, or social harm) than 
was previously known to an individual or group of individuals (including 
research subjects, research staff, or others not directly involved in the 
research). 
7.2 
Reporting Requirements for Unanticipated Problems 
7.2.1 
Reporting to the Principal Investigator (PI) 
The PI must be notified by study staff or co-investigators within 24 hours of 
learning of any UPIRSO, , occurring during the study as specified in section  
 
Phone Number for Expedited Reporting: 
Philip Chang, MD, 
Email: Philip.Chang@cshs.org  Ph: (310) 467-4498 
 
Alternate Phone Number for Expedited Reporting: 
Arash Asher, MD, 
Email: Arash.Asher@cshs.org Ph: (310) 423-1218 
7.2.2 
Reporting to Data and Safety Monitoring Committee (DSMC)  
UPIRSOs deemed to be related to the protocol and on-study deaths, including 
death of a research subject unless the death is expected (e.g. due to disease 
progression) to be reported to the DSMC within 24 hours of awareness. 
Hardcopies or electronic versions of the UPIRSO, along with any other 
supporting documentation available, should be submitted to the DSMC 
Coordinator. The DSMC Coordinator will forward the information to the DSMC 
Chair, and/or medical monitor. The DSMC Chair will review all UPIRSOs upon 
receipt from the DSMC Coordinator and determination of whether the following 
actions are required: 1) takes action immediately, 2) convenes a special DSMC 
session (physical or electronic), or 3) defers the action until a regularly scheduled 
DSMC meeting. Reports are to be emailed to the DSMC team at 
GroupSOCCICCTODSMCAdmin@cshs.org.  
7.2.3 
Reporting to the Institutional Review Board (IRB) 
The IRB must be notified within 10 business days of “any unanticipated problems 
involving risk to subjects or others.” 
1. Any serious event (injuries, side effects, deaths or other problems), which in 
the opinion of the PI was unanticipated, involved risk to subjects or others, and 
has a reasonable possibility of relationship to the research. 
2. Any serious accidental or unintentional change to the IRB-approved protocol 
that alters the level of risk. 
3. Any deviation from the protocol taken without prior IRB review to eliminate 
apparent immediate hazard to a research subject. 
4. Any new information (e.g., publication, safety monitoring report, updated 
sponsor safety report), interim result or other finding that indicates an 
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5. Any breach in confidentiality that may involve risk to the subject or others. 
6. Any complaint of a subject that indicates an unanticipated risk or that cannot be 
resolved by the PI. 
 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
Sample Size and Randomization 
We plan to enroll 16 patients to reach 80% power testing the hypothesis that the 
proportion of patients with attendance at least 60% of exercise sessions during the initial 
6-week period is greater than 50% using an one-sided exact Binomial test at 25% 
significance level. The actual significance level is 22.7%.  
8.2 
Data Sets Analyzed 
Data from all eligible subjects who have participated in a minimum of 60% of the exercise 
sessions will be analyzed.  
8.3 
Data Analyses/Study Endpoints 
Primary Objective: The primary analysis will test the hypothesis of feasibility using an 
one-sided exact Binomial test at 25% significance level. If 10 or more patients attend a 
minimum of 60% of exercise sessions during the initial 6-week period, then the study will 
be declared feasible. 
Secondary Endpoints: We will present descriptive measures for secondary endpoints with 
spaghetti and profile plots for repeated measures 
8.3.1 Safety Analysis 
All subjects entered into the study at Baseline will be included in the safety 
analysis. The frequencies of UPIRSOs by type, body system, severity and 
relationship to study intervention will be summarized.  
 
9.0 
STUDY MANAGEMENT 
9.1 
Conflict of Interest 
Any reportable conflict of interest will be disclosed to the local IRB and will be outlined in 
the Informed Consent Form. 
9.2 
IRB Approval and Consent  
It is expected that the IRB will have the proper representation and function in accordance 
with federally mandated regulations.  
 
Any documents that the IRB may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning 
patient recruitment, payment or compensation procedures, or other pertinent information) 
will be submitted to the IRB.  The IRBs written approval of the study protocol and the 
informed consent form will be in the possession of the PI before the study is initiated and 
prior to the shipment of study supplies to participating sites, if applicable.  This approval 
must refer to the study by exact protocol title and number and should identify the 
documents reviewed and the date of review. 
 

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In obtaining and documenting informed consent, the PI should comply with the applicable 
regulatory requirement(s) and should adhere to Good Clinical Practice (GCP) and to 
ethical principles that have their origin in the Declaration of Helsinki. 
 
 
Before recruitment and enrollment onto this study, the patient will be given a full 
explanation of the study and will be given the opportunity to review the consent form. 
Each consent form must include all the relevant elements currently required by the U.S 
Food and Drug Administration (FDA) Regulations and local or state regulations. Once 
this essential information has been provided to the patient and the PI is assured that the 
patient understands the implications of participating in the study, the patient will be asked 
to give consent to participate in the study by signing an IRB-approved consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form should be 
signed and personally dated by the patient and by the person who conducted the 
informed consent discussion. 
9.3 
Registration Procedures/Enrollment Procedures 
All patients will be tracked following written informed consent. Those patients who are 
consented to participate in the clinical trial but do not meet one or more criteria required 
for participation during the screening phase will be listed as screen failures on the master 
list of consented subjects.  Eligible subjects, as determined by screening procedures and 
verified by a treating investigator, will be registered on study at Cedars Sinai Medical 
Center by the Study Coordinator.   
 
Issues that would cause treatment delays after registration should be discussed with the 
PI. If a patient does not receive protocol therapy following registration, the patient’s 
registration on the study may be canceled.  The Study Coordinator should be notified of 
cancellations as soon as possible. 
 
Assignment of Subject ID: The study teams will track all subjects who sign consent using 
OnCore. Subjects found to be ineligible will be recorded as screen failures. Subjects 
found to be eligible will be registered using a three-digit numeric ID that follows the 
standard Samuel Oschin Comprehensive Cancer Institute (SOCCI) format (001, 002, 
etc.).  
 
A) 
Eligibility Verification 
 
Prior to registration, all subjects must undergo an eligibility verification by the study-
specific research staff. Minimal risk studies are exempt from SOCCI Quality Management 
Core (QMC) central eligibility checklist review and eligibility verification. QMC central 
eligibility checklist review and eligibility verification for all subjects enrolled is performed 
only if requested by the PI at any time during the life of the study. 
 
For patients requiring a protocol exception requestion and/or waiver due to eligibility 
concerns, refer to Section 9.7.2, Protocol Exceptions and Eligibility Waivers for 
instructions. 
 
B) 
Registration 
 
After eligibility is verified, each site will assign the subject a study number and site staff 
will then register the patient in OnCore®.   
 
 
Registration is completed as follows: 
 
• 
Assignment of a patient study number 

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• 
Enter the patient in OnCore 
• 
Notify the treating physician that a subject has gone on study and the anticipated 
start date 
 
Oversight by the PI is required throughout the entire registration process. 
9.4 
Data Management and Quality Control and Reporting 
REDCap is the Cedars-Sinai Cancer institutional choice for the electronic data capture of 
case report forms (CRF) for SOCCI Investigator Initiated Trials. REDCap, a HIPAA-
compliant database, will be used for electronic CRF in accordance with institutional 
requirements, as appropriate for the project. The Study Staff will be responsible for data 
processing, in accordance with procedural documentation. Database lock will occur once 
quality assurance procedures have been completed. 
 
All procedures for the handling and analysis of data will be conducted using good 
computing practices meeting FDA guidelines for the handling and analysis of data for 
clinical trials.  
9.5 
Data and Safety Monitoring 
9.5.1 
Safety Oversight 
Adherence to the protocol, Good Clinical Practices (GCP), and institutional policy 
will be monitored by the PI during the course of the study through routine 
Disease Research Group meetings (or equivalent). The PI will maintain 
continuous safety monitoring for the duration of the study by reviewing 
subject/study data. It is the responsibility of the principal investigator to adher to 
the Data Safety Monitoring Plan throughout the life of the study. 
In addition, safety oversight and efficacy data will be reviewed by the SOCC Data 
and Safety Monitoring Committee (DSMC). The DSMC will review this trial 
commensurate with the assigned risk class as categorized by the PRMC. The 
DSMC membership and responsibilities are governed by the committee charter. 
The DSMC findings and recommendations will be reported in writing to the 
Principal Investigator as a summary letter which will be forwarded by the 
Principal Investigator or designee to the CS-IRB. The DSMC outcome letters will 
be furnished to the FDA, as applicable. Refer to the DSMC Charter for details of 
the DSMC review.  
 
9.5.2 
Monitoring 
The SOCC Cancer Clinical Trials Office (CCTO) Quality Management Core 
(QMC) will conduct internal monitoring visits and audits to ensure that the rights 
and well-being of trial participants are protected, that the reported trial data are 
accurate, complete, and verifiable, and that the conduct of the trial is in 
compliance with the currently approved protocol/amendment(s), with 
International Conference on Harmonisation Good Clinical Practice (ICH GCP), 
and with applicable regulatory requirement(s). 
 
Refer to the DSMP for details pertaining to the type, frequency, and extent of 
monitoring that will be performed.   
9.6 
Record Retention 
 
Study documentation includes all CRFs, data correction forms or queries, source 
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destruction and regulatory documents (e.g., protocol and amendments, IRB 
correspondence and approval, signed patient consent forms). Source documents include 
all recordings of observations or notations of clinical activities and all reports and records 
necessary for the evaluation and reconstruction of the clinical research study. Government 
agency regulations and directives require that the study investigator must retain all study 
documentation pertaining to the conduct of a clinical trial. Study documents should be kept 
on file in accordance with all applicable federal guidelines and local guidelines. 
 
 
Investigators must make study data accessible to the monitor, other authorized 
representatives of the Sponsor (or designee), IRB, and Regulatory Agency (e.g., FDA) 
inspectors upon request. 
9.7 
Adherence to Protocol 
It is the responsibility of the Investigator-sponsor to ensure that patient recruitment and 
enrollment, treatment, follow-up for toxicities and response, and documentation and 
reporting at SOCCI are all performed as specified in the protocol. Except for an 
emergency situation in which proper care for the protection, safety, and well-being of the 
study patient requires alternative treatment, or a protocol exception request approved by 
the IRB of record, the study shall be conducted exactly as described in the approved 
protocol. 
 
9.7.1 
Emergency Modifications 
Investigators may implement a deviation from, or a change of, the protocol to 
eliminate an immediate hazard(s) to trial subjects without prior IRB approval. For 
any such emergency modification implemented, the IRB must be notified as soon 
as possible, but no more than 72 hours from the investigator’s awareness of the 
event. 
 
9.7.2 
Protocol Exceptions and Eligibility Waivers  
Minimal Risk 
A protocol exception is an anticipated or planned deviation from the IRB-
approved research protocol, as described in the CSMC IRB Policy, Reporting 
Possible Unanticipated Problems Involving Risks to Subject or Others (UPIRSO) 
Policy: Institutional Review Board/Research Compliance and Quality 
Improvement. A protocol exception most often involves a single subject and is 
not a permanent revision to the research protocol. Protocol exceptions that 
extend beyond a single subject should result in a protocol amendment to avoid 
serial violations.  
Planned exceptions to the protocol that are more than logistical in nature and/or 
impact an eligibility criterion, affect timing of study drug administration, or the 
investigator assesses the event may impact subject safety and/or study integrity, 
may not be implemented without prior IRB approval. The PI or their designee is 
responsible for submitting a protocol exception request and its supporting 
documents to the CSMC IRB if it meets the CSMC-IRB UPIRSO policy 
guidelines of a reportable exception/waiver. Study team should also refer to the 
IRB Reporting Possible Unanticipated Problems Involving Risks to Subject or 
Others (UPIRSO) Policy: Institutional Review Board/Research Compliance and 
Quality Improvement guidelines to determine which deviations and exception 
requests require IRB reporting. Once IRB approved, the deviation or exception 
can be implemented. 
 
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In general, subjects who do not meet the eligibility requirements should not be 
enrolled. In the rare event that it is appropriate for subject inclusion, the 
rationale/justification and subject case history should be submitted to the IRB for 
approval. Such requests for minimal risk studies do not require prior review by 
the CCTO Medical Director.  
 
9.7.3 
Other Protocol Deviations 
Logistical deviations from the protocol (e.g., minor changes to the study schedule 
for an individual subject) do not require prior IRB approval unless the deviation 
has the potential to affect the subject’s safety or study integrity. Such planned 
deviations that do meet this definition and do not affect the subject’s safety or 
study integrity should be noted in the subject’s research record or deviation log 
as described in the SOCCI CCTO’s Standard Operating Procedure 12: Deviation 
and Noncompliance Reporting.  
 
Unintentional deviations from the protocol that might affect subject safety or 
study integrity should be reported to the IRB within 10 days from when the 
investigator becomes aware that such a deviation has occurred, as outlined in 
the SOCCI CCTO’s Standard Operating Procedure 12: Deviation and 
Noncompliance Reporting (or local policy, for multi-site studies). In this case, a 
Protocol Deviation report must be submitted in CSMC-IRB, per CSMC IRB 
policy, Reporting Possible Unanticipated Problems Involving Risks to Subject or 
Others (UPIRSO) Policy: Institutional Review Board/Research Compliance and 
Quality Improvement. All submissions should include a description of the plan to 
avoid similar deviations or exceptions in the future.   
 
9.7.4 
Amendments to the Protocol  
Should amendments to the protocol be required, the amendments will be 
originated and documented by the PI. It should also be noted that when an 
amendment to the protocol substantially alters the study design or the potential 
risk to the patient, a revised consent form might be required.  
 
The written amendment, and if required the amended consent form, must be sent 
to the IRB for approval prior to implementation. Repeat exceptions or deviations 
to the protocol may suggest a protocol amendment is needed. 
 
9.8 
Obligations of Investigators 
 
The PI is responsible for the conduct of the clinical trial at the site in accordance with Title 
21 of the Code of Federal Regulations and/or the Declaration of Helsinki. The PI is 
responsible for personally overseeing the treatment of all study patients. The PI must 
assure that all study site personnel, including sub-investigators and other study staff 
members, adhere to the study protocol and all FDA/GCP regulations and guidelines 
regarding clinical trials both during and after study completion. 
 
 
The PI will be responsible for assuring that all the required data will be collected and 
entered onto the CRFs and/or into a HIPAA-compliant study database. Periodically, 
monitoring visits will be conducted, and the PI will provide access to their original records 
to permit verification of proper entry of data. At the completion of the study, all CRFs will 
be reviewed by the PI and will require their final signature to verify the accuracy of the 
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9.9 
Publications 
The preparation and submittal for publication of manuscripts containing the study results 
shall be in accordance with a process determined by mutual written agreement among 
the sponsor-investigator and participating institutions.  The publication or presentation of 
any study results shall comply with all applicable privacy laws, including, but not limited 
to, the Health Insurance Portability and Accountability Act of 1996.  
 

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10.0 
REFERENCES 
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2. 
Pancreatic Cancer - Risk Factors. Cancer.Net. Published June 25, 2012. Accessed September 22, 
2022. https://www.cancer.net/cancer-types/pancreatic-cancer/risk-factors 
3. 
Cooper AB, Holmes HM, des Bordes JKA, et al. Role of neoadjuvant therapy in the multimodality 
treatment of older patients with pancreatic cancer. J Am Coll Surg. 2014;219(1):111-120. 
doi:10.1016/j.jamcollsurg.2014.02.023 
4. 
Chan MY, Chok KSH. Sarcopenia in pancreatic cancer - effects on surgical outcomes and 
chemotherapy. World J Gastrointest Oncol. 2019;11(7):527-537. doi:10.4251/wjgo.v11.i7.527 
5. 
Sakamoto T, Yagyu T, Uchinaka E, et al. Sarcopenia as a prognostic factor in patients with 
recurrent pancreatic cancer: a retrospective study. World J Surg Oncol. 2020;18(1):221. 
doi:10.1186/s12957-020-01981-x 
6. 
Silver J. Cancer Prehabilitation in the Surgical Setting. In: Cancer Rehabilitation. 2nd ed. Springer 
Publishing Company; 2018:875-879. 
7. 
Loewen I, Jeffery CC, Rieger J, Constantinescu G. Prehabilitation in head and neck cancer patients: 
a literature review. J Otolaryngol Head Neck Surg. 2021;50(1):2. doi:10.1186/s40463-020-00486-7 
8. 
Bundred JR, Kamarajah SK, Hammond JS, Wilson CH, Prentis J, Pandanaboyana S. 
Prehabilitation prior to surgery for pancreatic cancer: A systematic review. Pancreatology. 
2020;20(6):1243-1250. doi:10.1016/j.pan.2020.07.411 
9. 
Hughes MJ, Hackney RJ, Lamb PJ, Wigmore SJ, Christopher Deans DA, Skipworth RJE. 
Prehabilitation Before Major Abdominal Surgery: A Systematic Review and Meta-analysis. World J 
Surg. 2019;43(7):1661-1668. doi:10.1007/s00268-019-04950-y 
10. 
Gillis C, Li C, Lee L, et al. Prehabilitation versus rehabilitation: a randomized control trial in patients 
undergoing colorectal resection for cancer. Anesthesiology. 2014;121(5):937-947. 
doi:10.1097/ALN.0000000000000393 
11. 
West MA, Loughney L, Lythgoe D, et al. Effect of prehabilitation on objectively measured physical 
fitness after neoadjuvant treatment in preoperative rectal cancer patients: a blinded interventional 
pilot study. Br J Anaesth. 2015;114(2):244-251. doi:10.1093/bja/aeu318 
12. 
Banerjee S, Manley K, Shaw B, et al. Vigorous intensity aerobic interval exercise in bladder cancer 
patients prior to radical cystectomy: a feasibility randomised controlled trial. Support Care Cancer. 
2018;26(5):1515-1523. doi:10.1007/s00520-017-3991-2 
13. 
Sebio Garcia R, Yáñez Brage MI, Giménez Moolhuyzen E, Granger CL, Denehy L. Functional and 
postoperative outcomes after preoperative exercise training in patients with lung cancer: a 
systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016;23(3):486-497. 
doi:10.1093/icvts/ivw152 
14. 
Cavalheri V, Granger C. Preoperative exercise training for patients with non-small cell lung cancer. 
Cochrane Database Syst Rev. 2017;6:CD012020. doi:10.1002/14651858.CD012020.pub2 
15. 
Ngo-Huang A, Parker NH, Bruera E, et al. Home-Based Exercise Prehabilitation During 
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and Quality of Life. Integr Cancer Ther. 2019;18:1534735419894061. 
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Smith SR, Vargo M, Zucker D, et al. Psychometric Characteristics and Validity of the PROMIS 
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Ausania F, Senra P, Meléndez R, Caballeiro R, Ouviña R, Casal-Núñez E. Prehabilitation in 
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Nakajima H, Yokoyama Y, Inoue T, et al. Clinical Benefit of Preoperative Exercise and Nutritional 
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Vargo M. Precautions in Cancer Rehabilitation. In: Cancer Rehabilitation. 2nd ed. Springer 
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20. 
Mohammed J, Aljurf M, Althumayri A, et al. Physical therapy pathway and protocol for patients 
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2019;12(3):127-132. doi:10.1016/j.hemonc.2018.12.003 
 
 
11.0 
APPENDIX  
11.1 
SUMMARY OF CHANGES 
11.1.1 Protocol v2, 17JUL2023 
1. Section 6.2.4, Review of SOC Lab Results: The absolute neutrophil count cut-off was 
reduced from 1.0 1000/uL to 0.5 1000/uL.  
2. Section 6.2.7, Online Pain Portal Training (first 8 participants only): Removal of Dr. 
Warner; the exercise physiologist/personal trainer staff will follow up with patients 
weekly to biweekly to record usage of the portal.    
3. Section 9.7.1, Emergency Modifications: Timeframe for IRB reporting changed from 
10 days to 72 hours. 
11.1.2 Protocol v3, 06AUG2024 
1. Updated cover page with version # and date. 
2. Updated biostatistician to Shaowli Kabir, PhD. 
3. Updated study summary to remove “ability to read, write and understand English” 
4. Removed inclusion criteria for “ability to read, write and understand English”  
5. Section 6.1.1 Informed Consent, it was added that “for non-English speaking 
patients, an interpreter will be used”. 
6. For sections 6.1.5, 6.1.6, 6.2.2, 6.3.2, 6.4.2, it was added that “for non-English 
speaking patients, an interpreter will be used for the questionnaires”.  
7. Updated language in sections 9.3 and 9.5 to match boilerplate protocol language. 
11.1.3 Protocol v3, 23JAN2025 
1. Updated cover page with version # and date 
2. Removed exclusion criteria 4.2.1 “has undergone or plans to undergo resection 
surgery prior to projected completion of PREHAB exercise intervention”. 
 

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