Resilience and Exercise in Advanced Cancer Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Adenocarcinoma Gastric Adenocarcinoma Adenocarcinoma of the Gastroesophageal Junction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Education

Distribution of exercise education materials

Group Type ACTIVE_COMPARATOR

Exercise Education

Intervention Type OTHER

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.

Band Together

A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.

Group Type EXPERIMENTAL

Band Together

Intervention Type BEHAVIORAL

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.

Interventions

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Band Together

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.

Intervention Type BEHAVIORAL

Exercise Education

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.

Intervention Type OTHER

Other Intervention Names

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strength training and walking program

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No