RecruitingNCT00493688
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Sponsor
M.D. Anderson Cancer Center
Enrollment
200 participants
Start Date
Oct 30, 2005
Study Type
OBSERVATIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria10
- 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.
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Interventions
OTHERCardiopulmonary Exercise Testing (CPET)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT00493688
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