Clinical trial NCT02235441: Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies
Official title: Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pathologically Proven Gastrointestinal Malignancy
Plan of Care Must Include Chemoradiation
Keywords: Gastrointestinal malignancy
Cardiopulmonary fitness
Chemoradiation therapy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed gastrointestinal malignancy
2. Plan for chemoradiation
3. At least 18 years old
4. Karnofsky performance status of at least 70% at study entry
5. Ability to read and understand English
6. Signed informed consent prior to initiation of study-related procedures
7. All women of childbearing potential must have a negative serum pregnancy test prior to study entry

Exclusion Criteria:

1. Significant cardiac disease (i.e., left ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
2. 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
3. KPS\<70%
4. Females who are pregnant

Primary outcomes:
measure: Feasibility Composite Score
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Joan Cahill
state: North Carolina
Study officials:
affiliation: Duke Health
name: Manisha Palta, MD
role: PRINCIPAL_INVESTIGATOR
References: