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

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT04802486

Collaborator

(none)

Enrollment

Location

Arms

31.6

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cachexia Weight Loss Gastrointestinal Cancer	Other: EXCAP©®	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jun 29, 2016

Actual Primary Completion Date :

Feb 15, 2019

Actual Study Completion Date :

Feb 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of patients that adhered to the exercise conditions of the study [3 Months]
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).