Resilience and Exercise in Advanced Cancer Treatment (REACT)

February 26, 2018 updated by: Amanda Cooper, MD, Milton S. Hershey Medical Center

Prehabilitation for Patients With Aggressive Gastrointestinal Cancers Undergoing Neoadjuvant Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise Education
Distribution of exercise education materials
Other: 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.
Experimental: Band Together
A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.
Behavioral: 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.
Other Names:
  • strength training and walking program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Large-Scale Trial: Adherence & Contamination
Time Frame: Throughout the course of neoadjuvant therapy (on average 10-12 weeks)
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.
Throughout the course of neoadjuvant therapy (on average 10-12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate
Time Frame: Completion of neoadjuvant therapy (on average 10-12 weeks)
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.
Completion of neoadjuvant therapy (on average 10-12 weeks)
Exercise Partner Benefits
Time Frame: Completion of neoadjuvant therapy (on average 10-12 weeks)
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.
Completion of neoadjuvant therapy (on average 10-12 weeks)
Change in grip strength and upper body strength as a result of intervention
Time Frame: Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks)
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.
Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks)
Assessing the interaction between frailty and the Band Together program
Time Frame: Completion of neoadjuvant therapy (on average 10-12 weeks)
Frail subjects will be identified using Fried's Frailty Criteria and compared to non-frail subjects using the outcome measures described above.
Completion of neoadjuvant therapy (on average 10-12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Amanda B Cooper, MD, Penn State College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Adenocarcinoma

Clinical Trials on Exercise Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe