NCT02235441|Terminated
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Sponsor study identifier
interventional
8
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 5, 2016
Actual (reported)Study Completion
April 5, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 5, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 29, 2014
Actual (reported)September 10, 2014
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 5, 2016
Actual (reported)April 5, 2016
Actual (reported)Feasibility Composite Score
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), and (c) no more than 1 patient has an exercise-related adverse event.
36 months
All eligible subjects will participate in treadmill exercise to measure cardiopulmonary fitness during chemoradiation therapy.
All subjects will undergo a maximal cardiopulmonary exercise test and resting metabolic rate study. Prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing.This exercise test involves exercising on a treadmill to maximal exertion, during which the subject's breathing and oxygen consumption are measured. The subject will wear nose clips to prevent exhaling air through their nose and a mouth piece that will allow all exhaled air to be analyzed through the metabolic cart. The subject's electrocardiogram (ECG), blood pressure, and perceived exertion are monitored throughout the test by trained personnel.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Joan Cahill
Durham, North Carolina, 27710, United States
Manisha Palta, MD
Duke Health
8 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2014
First Posted
September 10, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group ( SONEX )
Contact the study team to confirm eligibility.
Primary Completion
April 5, 2016
Actual (reported)Study Completion
April 5, 2016
Actual (reported)Last Updated
July 11, 2017
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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