Resilience and Exercise in Advanced Cancer Treatment

Milton S. Hershey Medical Center14 enrolled

Overview

This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.

A growing body of evidence suggests host resilience (lack of frailty, skeletal muscle reserve, etc.) may impact early healing, recovery following neoadjuvant therapy and surgery, and long-term cancer-free survival. It is well-recognized that resilience is enhanced in individuals with proper diet, sleep habits, and exercise. However, it is unknown whether such resilience can be enhanced by training programs initiated at the time of cancer diagnosis. Although exercise interventions may contribute to these improvements, it is unknown how willing and able these patients are to comply with an exercise regimen during the neoadjuvant therapy period. The aim of this study, therefore, is to evaluate compliance with and the efficacy of Band Together, an exercise program combining strength-training and aerobic exercise, in patients with aggressive GI malignancies undergoing neoadjuvant therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Adenocarcinoma Gastric Adenocarcinoma Adenocarcinoma of the Gastroesophageal Junction

Interventions

Band TogetherBEHAVIORAL

Band Together is a strength training program utilizing resistance bands with progressively increasing resistance, ranging from 3 to 35 pounds. Sessions are to be completed 3 times a week and involve 3 sets of 6 exercises: 1. chair stands, 2. chest press, 3. shoulder press, 4. arm curls, 5. pulls, and 6. calf raises. In addition, Band Together participants will be asked to work up to a walking goal of 10,000 additional steps per week.

Exercise EducationOTHER

Education will consist of counseling by the healthcare provider with supplemental handouts from the American College of Sports Medicine and the National Institute on Aging/ National Institutes of Health.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 years or older 2. New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction. 3. Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation. 4. Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers. 5. The ability to speak and read English. 6. The ability to provide informed consent. Exclusion Criteria: 1. Angina (stable or unstable) 2. Paraplegia or quadriplegia 3. Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands. 4. Patients who have already started neoadjuvant chemotherapy at other institutions. 5. Presence of metastatic disease. 6. Gastric or pancreatic histologies other than adenocarcinoma. 7. Pregnant women. 8. Prisoners 9. Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Feasibility of Large-Scale Trial: Adherence & Contamination

The mean adherence rates (percentage of prescribed sessions completed) in the intervention group will be determined based on weekly activity diaries. Activity diaries will be completed by the subject throughout their participation in the study and collected upon the end of participation. The mean contamination rates (completed exercise sessions) in the control group will also be determined based on weekly activity diaries.

Time frame: Throughout the course of neoadjuvant therapy (on average 10-12 weeks)

Secondary Outcomes

Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate

Potential subjects will be screened using the Physical Activity Readiness Questionnaire; those who may not be ready to begin an exercise program will be ineligible. The proportion of patients who are PAR-Q ineligible will be compared to the proportion of patients who are eligible based on their PAR-Q results. The proportion of patients who are ineligible due to other exclusion criteria will also be compared. All eligible patients who decline to participate in the study will be asked to provide a reason for their decision; the proportion of potential subjects who decline will be compared to the proportion of subjects who do consent and are eligible.

Time frame: Completion of neoadjuvant therapy (on average 10-12 weeks)

Exercise Partner Benefits

The mean adherence rates (percentage of prescribed sessions completed) for subjects in the intervention group who have an exercise partner participate in ≥50% of their exercise sessions will be compared to those of subjects who have an exercise partner for \<50% of their exercise sessions.

Time frame: Completion of neoadjuvant therapy (on average 10-12 weeks)

Change in grip strength and upper body strength as a result of intervention

Subjects will be tested before starting neoadjuvant therapy using a dynamometer and a hanging scale, and then again after completing neoadjuvant therapy, to determine if their grip strength and/or upper body strength have changed from baseline.

Data from ClinicalTrials.gov

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