The Effects of a 12 Week Home-based Exercise Intervention on Physical Performance in Patients With Cancers of the Gastrointestinal Tract With Pre- Cachexia or Cachexia
Primary Purpose
Cachexia, Weight Loss, Gastrointestinal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EXCAP©®
Sponsored by
About this trial
This is an interventional supportive care trial for Cachexia focused on measuring Cachexia, Weight Loss, Exercise, Gastrointestinal Cancer
Eligibility Criteria
Inclusion Criteria:
- Have a primary diagnosis of colorectal, esophageal, gastric, pancreatic or biliary tract cancer and plans to initiate systemic chemotherapy within the next 4 weeks after enrollment.
- Have been diagnosed as having an advanced unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
- Have an ECOG performance score of 0 or 1.
- Have a life expectancy of >3 months as determined by their primary oncologist.
- Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment. Patients who have 2 - 4.9% weight loss should also have one of the following metabolic changes: a hemoglobin level <13, an albumin level <3.5, and/or impaired glucose tolerance within the past year such as a new diagnosis of diabetes, an A1C level >5.7, a random glucose level >200 or a fasting glucose level >100.
- Have permission from primary oncologist to engage in low to moderate intensity exercise regimen.
- Be able to read English (since the assessment materials are in printed format).
- Be able to give written informed consent.
Exclusion Criteria:
- Have any of the following limitations: unable to walk the 4 meters of the SPPB test, wheel-chair bound, unable to perform low-to-moderate intensity exercise regimen (patients unable to perform 6 minute walk or stair climb test will be allowed to participate, but will be held out of these measurements).
- Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
- Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
- Be enrolled on hospice at time of consent.
- Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (40).
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm 1: Exercise Intervention and Standard Care
Arm 2: Standard Care
Arm Description
A home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
Standard care for your cancer as prescribed by your oncologist
Outcomes
Primary Outcome Measures
Number of patients that adhered to the exercise conditions of the study
Measured by the Short Physical Performance Battery (SPPB) in patients with advanced GI malignancies
Secondary Outcome Measures
Porportion of subjects with improved cachexia-related symptoms 3 months
The Functional Assessment of Anoreix/Cachexia Therapy subscale is a 39-item questionnaire that measures general aspects of quality of life as well as specific anorexia/cachexia-related concerns. This will be collected at pre- and post intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04802486
Brief Title
The Effects of a 12 Week Home-based Exercise Intervention on Physical Performance in Patients With Cancers of the Gastrointestinal Tract With Pre- Cachexia or Cachexia
Official Title
Evaluating the Effects of a 12 Week Home-based Exercise Intervention on Physical Performance in Patients With Cancers of the Gastrointestinal Tract With Pre- Cachexia or Cachexia: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this research study is to determine if exercise improve or worsen cachexia.
Detailed Description
In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise may impact this process. The investigator would like to see whether a progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this exercise intervention improves physical performance, day-to-day function, quality of life, and how exercise may affect different markers in the blood over time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Weight Loss, Gastrointestinal Cancer
Keywords
Cachexia, Weight Loss, Exercise, Gastrointestinal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Exercise Intervention and Standard Care
Arm Type
Experimental
Arm Description
A home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
Arm Title
Arm 2: Standard Care
Arm Type
No Intervention
Arm Description
Standard care for your cancer as prescribed by your oncologist
Intervention Type
Other
Intervention Name(s)
EXCAP©®
Intervention Description
EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises
Primary Outcome Measure Information:
Title
Number of patients that adhered to the exercise conditions of the study
Description
Measured by the Short Physical Performance Battery (SPPB) in patients with advanced GI malignancies
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Porportion of subjects with improved cachexia-related symptoms 3 months
Description
The Functional Assessment of Anoreix/Cachexia Therapy subscale is a 39-item questionnaire that measures general aspects of quality of life as well as specific anorexia/cachexia-related concerns. This will be collected at pre- and post intervention
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a primary diagnosis of colorectal, esophageal, gastric, pancreatic or biliary tract cancer and plans to initiate systemic chemotherapy within the next 4 weeks after enrollment.
Have been diagnosed as having an advanced unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
Have an ECOG performance score of 0 or 1.
Have a life expectancy of >3 months as determined by their primary oncologist.
Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment. Patients who have 2 - 4.9% weight loss should also have one of the following metabolic changes: a hemoglobin level <13, an albumin level <3.5, and/or impaired glucose tolerance within the past year such as a new diagnosis of diabetes, an A1C level >5.7, a random glucose level >200 or a fasting glucose level >100.
Have permission from primary oncologist to engage in low to moderate intensity exercise regimen.
Be able to read English (since the assessment materials are in printed format).
Be able to give written informed consent.
Exclusion Criteria:
Have any of the following limitations: unable to walk the 4 meters of the SPPB test, wheel-chair bound, unable to perform low-to-moderate intensity exercise regimen (patients unable to perform 6 minute walk or stair climb test will be allowed to participate, but will be held out of these measurements).
Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
Be enrolled on hospice at time of consent.
Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (40).
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of a 12 Week Home-based Exercise Intervention on Physical Performance in Patients With Cancers of the Gastrointestinal Tract With Pre- Cachexia or Cachexia
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