Assessing energy dynamics and postoperative outcomes in cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.