Back to resultsResilience and Exercise in Advanced Cancer Treatment (REACT)
Primary Purpose
Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Band Together
Exercise Education
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.
- Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.
- Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.
- The ability to speak and read English.
- The ability to provide informed consent.
Exclusion Criteria:
- Angina (stable or unstable)
- Paraplegia or quadriplegia
- Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.
- Patients who have already started neoadjuvant chemotherapy at other institutions.
- Presence of metastatic disease.
- Gastric or pancreatic histologies other than adenocarcinoma.
- Pregnant women.
- Prisoners
- Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)
Sites / Locations
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Exercise Education
Band Together
Arm Description
Distribution of exercise education materials
A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Assessing the interaction between frailty and the Band Together program
Frail subjects will be identified using Fried's Frailty Criteria and compared to non-frail subjects using the outcome measures described above.
Full Information
NCT ID
NCT02680990
First Posted
November 25, 2015
Last Updated
February 26, 2018
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02680990
Brief Title
Resilience and Exercise in Advanced Cancer Treatment
Acronym
REACT
Official Title
Prehabilitation for Patients With Aggressive Gastrointestinal Cancers Undergoing Neoadjuvant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Education
Arm Type
Active Comparator
Arm Description
Distribution of exercise education materials
Arm Title
Band Together
Arm Type
Experimental
Arm Description
A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.
Intervention Type
Behavioral
Intervention Name(s)
Band Together
Other Intervention Name(s)
strength training and walking program
Intervention Description
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
Other
Intervention Name(s)
Exercise Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Large-Scale Trial: Adherence & Contamination
Description
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 Outcome Measure Information:
Title
Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate
Description
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)
Title
Exercise Partner Benefits
Description
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)
Title
Change in grip strength and upper body strength as a result of intervention
Description
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.
Time Frame
Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks)
Title
Assessing the interaction between frailty and the Band Together program
Description
Frail subjects will be identified using Fried's Frailty Criteria and compared to non-frail subjects using the outcome measures described above.
Time Frame
Completion of neoadjuvant therapy (on average 10-12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.
Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.
Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.
The ability to speak and read English.
The ability to provide informed consent.
Exclusion Criteria:
Angina (stable or unstable)
Paraplegia or quadriplegia
Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.
Patients who have already started neoadjuvant chemotherapy at other institutions.
Presence of metastatic disease.
Gastric or pancreatic histologies other than adenocarcinoma.
Pregnant women.
Prisoners
Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda B Cooper, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25519927
Citation
Cooper AB, Slack R, Fogelman D, Holmes HM, Petzel M, Parker N, Balachandran A, Garg N, Ngo-Huang A, Varadhachary G, Evans DB, Lee JE, Aloia T, Conrad C, Vauthey JN, Fleming JB, Katz MH. Characterization of Anthropometric Changes that Occur During Neoadjuvant Therapy for Potentially Resectable Pancreatic Cancer. Ann Surg Oncol. 2015 Jul;22(7):2416-23. doi: 10.1245/s10434-014-4285-2. Epub 2014 Dec 18.
Results Reference
background
PubMed Identifier
24096757
Citation
Dale W, Hemmerich J, Kamm A, Posner MC, Matthews JB, Rothman R, Palakodeti A, Roggin KK. Geriatric assessment improves prediction of surgical outcomes in older adults undergoing pancreaticoduodenectomy: a prospective cohort study. Ann Surg. 2014 May;259(5):960-5. doi: 10.1097/SLA.0000000000000226.
Results Reference
background
PubMed Identifier
24374288
Citation
van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
Results Reference
background
PubMed Identifier
23064817
Citation
Bollwein J, Diekmann R, Kaiser MJ, Bauer JM, Uter W, Sieber CC, Volkert D. Dietary quality is related to frailty in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2013 Apr;68(4):483-9. doi: 10.1093/gerona/gls204. Epub 2012 Oct 12.
Results Reference
background
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Resilience and Exercise in Advanced Cancer Treatment
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