Clinical trial NCT04837118: Resistance Training Intervention to Improve Physical Function in Patients With Pancreatic Cancer Receiving Combination Chemotherapy or Have Undergone Surgery, PancStrength Study
Official title: PancStrength: Safety, Feasibility, and Acceptability of a Tele-Exercise Resistance Training Intervention During Pancreatic Cancer Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies the safety of a real-time tele-exercise resistance training (training done using a tablet) in maintaining skeletal muscle, strength, physical function, and health-related quality of life in patients with pancreatic cancer who are receiving combination chemotherapy or have undergone surgery for the treatment of pancreatic cancer. Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer.

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate the safety of a progressive, home-based, tele-exercise resistance training (tele-RT) intervention in patients undergoing first line FOLFIRINOX chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) (Study 1) and in survivors who have undergone pancreatic cancer resection (Study 2).

SECONDARY OBJECTIVES:

I. Evaluate the feasibility and acceptability of the tele-RT intervention.

II. Evaluate changes in the following exploratory outcome measures over the course of first-line FOLFIRINOX for advanced PDAC and associations between resistance training (RT) volumes and their changes:

IIa. Muscular strength IIb. Muscular endurance IIc. Body composition (skeletal muscle mass) IId. Aerobic fitness IIe. Self-reported physical activity IIf. Self-reported physical functioning IIg. Fatigue IIh. Peripheral neuropathy IIi. Health-related quality of life (QOL) IIj. Completion of intended chemotherapy dose (Among patients who are undergoing chemotherapy; all participants in Study 1 and some in Study 2) IIk. Exercise motivation IIl. Exercise self-efficacy IIm. Social support for exercise IIn. Reduction or change in FOLFIRINOX treatment plan III. Evaluate cancer care providers' (treating physicians and other clinical personnel) perspectives regarding the feasibility and acceptability of the tele-RT intervention for their patients.

OUTLINE:

STUDY 1: During the first 2-3 months of first line FOLFIRINOX chemotherapy, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks. Patients receive handouts created by MD Anderson Cancer Center (MDACC) clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.

STUDY 2: After standard of care surgical resection, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks for 2-3 months. Patients receive handouts created by MDACC clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven pancreatic adenocarcinoma, advanced stage (III-IV) (study 1) OR biopsy-proven pancreatic adenocarcinoma, at least 10 weeks post-surgical tumor resection and currently with no radiographic evidence of disease on recent computerized tomography (CT) scan (study 2)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Treatment plan of first-line FOLFIRINOX chemotherapy with planned return visit to MD Anderson Main Campus for restaging (study 1) OR plans to return to MDACC for restaging appointments in 3-4 months, including follow up CT scan (study 2)
* Able to schedule baseline (T0) appointment for fitness testing and program teaching at the Behavioral Research and Treatment Center (BRTC) or able to schedule remote fitness testing and program teaching
* Able to understand the description of the study, exercise program, and willing to participate
* Home access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions
* Age \>= 18
* Meet all screening requirements
* PROVIDERS (FOR ACCEPTABILITY INTERVENTION): All GI medical oncologists, GI surgeons, advanced practice providers, and clinical dietitians who are involved in participants' care and have some interaction with intervention personnel during recruitment, referral, scheduling, or follow up will be asked to complete questionnaires assessing intervention acceptability. The exact number of providers who will be asked to complete questionnaires will depend on whether patients enroll from the different GI Medical Oncology and GI Surgery clinics, but we expect 10-20 providers to be eligible

Exclusion Criteria:

* Non-English speaking
* Has participated in regular RT (RT for all major muscle groups at least twice per week) throughout the month prior to recruitment
* Unable to complete the baseline assessment questionnaires or functional assessments
* Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and/or Patient Reported Outcomes Measurement Information System (PROMIS) questions
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
* Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
* Numeric pain rating scale of \>= 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function
* FEMALES ONLY: Known pregnancy, as communicated to study personnel by clinicians in gastrointestinal (GI) Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care

Primary outcomes:
measure: Safety of the tele-resistance training (RT) program
timeFrame: 3-4 months
measure: Post-exercise muscle soreness
timeFrame: 3-4 months
measure: Body composition
timeFrame: 3-4 months
measure: Aerobic fitness
timeFrame: 3-4 months
Secondary outcomes:
measure: Acceptability for Feasibility
timeFrame: 3-4 months
measure: Acceptability for participants
timeFrame: 3-4 months
measure: Acceptability for providers
timeFrame: 3-4 months
measure: Dynamic upper- and lower-body muscular strength
timeFrame: 3-4 months
measure: Dynamic upper- and lower-body muscular endurance
timeFrame: 3-4 months
measure: Fatigue
timeFrame: 3-4 months
measure: Chemotherapy-induced peripheral neuropathy (CIPN)
timeFrame: 3-4 months
measure: Health-related QOL
timeFrame: 3-4 months
measure: Chemotherapy tolerance and delivery
timeFrame: 3-4 months
measure: Exercise motivation
timeFrame: 3-4 months
measure: Exercise barriers self-efficacy
timeFrame: 3-4 months
measure: Social support for exercise
timeFrame: 3-4 months
measure: Self-reported physical activity
timeFrame: 3-4 months
measure: Self-reported physical functioning
timeFrame: 3-4 months
measure: Feasibility of Automated Self Assisted 24-hour recall (ASA24) (24-hour dietary recall)
timeFrame: At time of enrollment up to 7-10 days before date of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, BA,MPH,PHD
role: PRINCIPAL_INVESTIGATOR
References: