NCT00493688 A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
| NCT ID | NCT00493688 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Abdominal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2005-10-30 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2005-10-30 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Anh Dang, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT00493688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00493688 currently recruiting?
Yes, NCT00493688 is actively recruiting participants. Contact the research team at adang@mdanderson.org for enrollment information.
Where is the NCT00493688 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT00493688 clinical trial?
NCT00493688 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Anh Dang, MD at M.D. Anderson Cancer Center. The trial plans to enroll 200 participants.
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