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

NCT04802486 | Completed DMC

• 1 other identifier: UGIM16011
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cachexia; Weight Loss; Gastrointestinal Cancer

Keywords

Cachexia; Weight Loss; Exercise; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  3 Months

Secondary Outcomes (1)

• Porportion of subjects with improved cachexia-related symptoms 3 months

  3 Months

Study Arms (2)

Arm 1: Exercise Intervention and Standard Care

EXPERIMENTAL

A home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist

Other: EXCAP©®

Arm 2: Standard Care

NO INTERVENTION

Standard care for your cancer as prescribed by your oncologist

Interventions

EXCAP©® OTHER

EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises

Arm 1: Exercise Intervention and Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cachexia; Weight Loss; Gastrointestinal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Medicine , Hematology/Oncology

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: June 29, 2016
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)