Clinical trial NCT03256201: Exercise and Nutrition to Improve Pancreatic Cancer Outcomes
Official title: Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Cancer
prehabilitation
sarcopenia
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 95
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.

Detailed description: This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery.

In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.

Eligibility criteria: Inclusion:

* Individuals with suspected pancreatic or related tumor for surgical resection by pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are eligible provided they are approved for exercise participation by pancreatic clinic team.
* Cognition and English language skills must be sufficient for completion of consent and questionnaires.
* Age \>30.
* Able to rise from a chair and walk household distances without assist from another person.
* Willing to be randomized to one of two pre-operative home-based exercise programs, without knowing the difference between the two, and use protein supplementation if instructed.

Exclusion:

* Individuals are excluded if they are unsafe (according to the study team) based on current MD recommendation not to exercise, medical history, recent fracture or high-risk bone lesion, or neurologic disorder with safety concerns.
* Participants cannot have an allergy to whey protein, or abnormal response to baseline physical performance tests of walking endurance and strength.
* Those who currently participate in a regular and substantial (as defined by the study team) strengthening or protein supplementation program are eligible only for the 'for assessment only' observational version of the study, but will not be included in the randomized trial.

Primary outcomes:
measure: Accrual
timeFrame: 2 year
measure: Retention
timeFrame: 2 year
measure: Adherence
timeFrame: 2 year
Secondary outcomes:
measure: Quality of Life Assessment
timeFrame: Approximately 1-3 days pre-op
measure: Change in Body Weight
timeFrame: Approximately 1-3 days pre-op
measure: Change in Body Weight
timeFrame: Approximately 1-3 days pre-op
measure: Physical Performance
timeFrame: Approximately 1-3 days pre-op
measure: Physical Performance
timeFrame: Approximately 2-4 weeks pre-op
measure: Physical Performance
timeFrame: Approximately 1-3 days pre-op
measure: Physical Performance
timeFrame: Approximately 4 months post-op
measure: Assessment of Symptoms
timeFrame: Approximately 4 weeks post-op
measure: Assessment of Symptoms
timeFrame: Approximately 1-3 days pre-op
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Faculty
name: Elizabeth Hile, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: