Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies

NCT02235441 | Terminated

• 1 other identifier: Pro00055718
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pathologically Proven Gastrointestinal Malignancy; Plan of Care Must Include Chemoradiation

Keywords

Gastrointestinal malignancy; Cardiopulmonary fitness; Chemoradiation therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cardiopulmonary Fitness

EXPERIMENTAL

All eligible subjects will participate in treadmill exercise to measure cardiopulmonary fitness during chemoradiation therapy.

Other: Cardiopulmonary Exercise Test (CPET)

Interventions

Cardiopulmonary Exercise Test (CPET) OTHER

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.

Also known as: Treadmill exercise

Cardiopulmonary Fitness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Joan Cahill

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Manisha Palta, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 10, 2014
• Study Start: November 1, 2014
• Primary Completion: April 5, 2016
• Study Completion: April 5, 2016
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (1)