Status:
TERMINATED
Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies
Lead Sponsor:
Duke University
Conditions:
Pathologically Proven Gastrointestinal Malignancy
Plan of Care Must Include Chemoradiation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed gastrointestinal malignancy
- Plan for chemoradiation
- At least 18 years old
- Karnofsky performance status of at least 70% at study entry
- Ability to read and understand English
- Signed informed consent prior to initiation of study-related procedures
- All women of childbearing potential must have a negative serum pregnancy test prior to study entry
Exclusion
- Significant cardiac disease (i.e., left ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
- Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases
- KPS\<70%
- Females who are pregnant
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02235441
Start Date
November 1 2014
End Date
April 5 2016
Last Update
July 11 2017
Active Locations (1)
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1
Joan Cahill
Durham, North Carolina, United States, 27710