Resilience and Exercise in Advanced Cancer Treatment (REACT)

Penn State Health

Status: Completed

Conditions: Pancreatic Adenocarcinoma; Adenocarcinoma of the Gastroesophageal Junction; Gastric Adenocarcinoma

Treatments: Behavioral: Band Together; Other: Exercise Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02680990

STUDY00002745

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Exercise Education

Active Comparator group

Description:

Distribution of exercise education materials

Treatment:

Other: Exercise Education

Band Together

Experimental group

Description:

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

Treatment:

Behavioral: Band Together