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

March 16, 2021 updated by: Richard Dunne, University of Rochester

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

The main purpose of this research study is to determine if exercise improve or worsen cachexia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

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
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

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:

  • 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).

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: Exercise Intervention and Standard Care
A home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
Other: EXCAP©®
EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises
NO_INTERVENTION: Arm 2: Standard Care
Standard care for your cancer as prescribed by your oncologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients that adhered to the exercise conditions of the study
Time Frame: 3 Months
Measured by the Short Physical Performance Battery (SPPB) in patients with advanced GI malignancies
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Porportion of subjects with improved cachexia-related symptoms 3 months
Time Frame: 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
3 Months

Collaborators and Investigators

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

Sponsor

University of Rochester

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 (ACTUAL)

June 29, 2016

Primary Completion (ACTUAL)

February 15, 2019

Study Completion (ACTUAL)

February 15, 2019

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (ACTUAL)

March 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGIM16011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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