Assessing energy dynamics and postoperative outcomes in cancer surgery
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
This study is testing a new way to check how well patients with esophageal and lung cancer can handle surgery by measuring their energy levels before the operation to see if it affects their recovery afterwards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT00493688 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a new method for assessing perioperative risk in patients undergoing major cancer surgery. Researchers will measure preoperative energy reserve capacity using cardiopulmonary exercise testing (CPET) and determine if postoperative morbidity is influenced by perioperative gas exchange metabolism. The primary objective is to characterize the effects of neoadjuvant therapy on functional capacity in patients with esophageal and lung cancer. Secondary objectives include correlating changes in CPET measures with postoperative outcomes following treatment and surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed esophageal or lung cancer undergoing neoadjuvant therapy.
Not a fit: Patients who are under 18, unable to exercise, or unwilling to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the assessment of surgical risk and postoperative outcomes for cancer patients.
How similar studies have performed: Other studies have shown success in using CPET to assess perioperative risk, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Anh Dang, MD — M.D. Anderson Cancer Center
- Study coordinator: Anh Q Dang, MD
- Email: adang@mdanderson.org
- Phone: 713-745-5025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.