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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

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.

Study details
    Abdominal Cancer
    Pelvic Cancer

NCT00493688

M.D. Anderson Cancer Center

13 August 2025

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