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NCT02235441 · ClinicalTrials.gov registry record · NA
Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT02235441: Clinical Trial NA study, sponsored by Duke University.
NCT02235441 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02235441, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
There is growing evidence of the integral role of exercise following cancer treatment. Randomized trials show that exercise improves post treatment symptoms and quality of life in breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50% relative risk reduction in cancer specific death and 20-50% relative risk reduction in all cause mortality have been reported with exercise. At present it is unknown if preclinical pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before launching into further studies of exercise training on changes in tumor hypoxia and response to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures of exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2. Whether changes in measures of exercise exposure over the course of CRT are related to changes in tumor hypoxia and response to CRT.
Primary Outcome
The primary objective is to determine the feasibility of assessing cardiopulmonary fitness pre and post chemoradiation therapy. This feasibility assessment will be reported as a composite of the following variables: (a) the study can accrue 25 patients in no more than 3 years, (b) at least 18 of these 25 patients adhere to the cardiopulmonary testing pre and post CRT; do not drop out early, and do not have an exercise-related adverse event (i.e., cardiac arrhythmias or myocardial infarction), an
Interventions
- OTHER Cardiopulmonary Exercise Test (CPET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-04-05 |
| Phase | NA |
Why NCT02235441 stopped before completion
NCT02235441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Cardiopulmonary Exercise Test (CPET) is the first listed.
NCT02235441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02235441 about?
NCT02235441 is a clinical study titled "Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies". There is growing evidence of the integral role of exercise following cancer treatment. Randomized trials show that exercise improves post treatment symptoms and quality of life in breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause mortality for patients with b...
What is the current status of trial NCT02235441?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2014-11. Estimated completion is 2016-04-05.
What interventions are being tested in trial NCT02235441?
The interventions under investigation include: Cardiopulmonary Exercise Test (CPET) (OTHER).
Who is sponsoring clinical trial NCT02235441?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02235441's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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