Clinical trial · Interventional
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
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
NCT04802486CI-TRIAL-00050688completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this research study is to determine if exercise improve or worsen cachexia.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXCAP©® | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Exercise Intervention and Standard Care
- description
- A home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist
- interventionNames
- Other: EXCAP©®
- type
- NO_INTERVENTION
- label
- Arm 2: Standard Care
- description
- Standard care for your cancer as prescribed by your oncologist
Primary outcomes (1)
- measure
- Number of patients that adhered to the exercise conditions of the study
- timeFrame
- 3 Months
- description
- Measured by the Short Physical Performance Battery (SPPB) in patients with advanced GI malignancies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.