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NCT Number: NCT00493688

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

MD Anderson General Health Specialist

CONTACT

877-632-6789

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiopulmonary Exercise Testing (CPET)

Other

Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.

Primary outcomes

  1. Patient Perioperative Risk

    Time frame: Baseline + 30 days postoperatively monitoring for morbid events

    Measure preoperative energy reserve capacity (fitness) using perioperative energy dynamics where fitness is defined by gas exchange data during cardiopulmonary exercise testing as method of assessing perioperative risk

Study contacts

Contact information is provided by the study sponsor or research team.

Anh Q Dang, MD

CONTACT

[email protected]

713-745-5025

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2005
Primary completion
2028
Study completion
2028
First posted
Jun 28, 2007
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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