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NCT00493688Recruiting

A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

M.D. Anderson Cancer Center

Start Date

10/30/2005

Completion Date

10/30/2028

Summary

To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery. In this proposed study researchers will: 1. Measure preoperative energy reserve capacity (fitness) 2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

Detailed Description

Primary Objective: • To characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or immunotherapy) on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters (%predicted AT, %predicted P-VO2, VO2 at AT \& peak exercise, oxygen pulse, ΔVO2/ΔWR, ΔVE/ΔVCO2) obtained from CPET before and after neoadjuvant therapy. Secondary Objectives: • To characterize changes in CPET measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants 18 years of age or older. * Participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and/or immunotherapy. * Participants who have signed the consent form to participate in the study. * Participants must have been evaluated in the Perioperative Evaluation and Management (POEM) Center or by a staff Anesthesiologist. * All laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. All participants must be approved to undergo anesthesia by the standards of the POEM Center. * No samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation. Exclusion Criteria: * Participant is under age 18. * Participant is unwilling to sign consent. * Participant is unable to exercise (bedridden or wheel chair bound). * Participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC. * Participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation. * Participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina. * Participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation. * Participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation. * Participant is known to have acute or chronic deep vein thrombosis. * Participant is pregnant.

Interventions

OTHER

Cardiopulmonary Exercise Testing (CPET)

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Conditions

Abdominal CancerPelvic Cancer

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States