Recruiting

Observational StudyA Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00493688

Conditions

Abdominal Cancer

Pelvic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiopulmonary Exercise Testing (CPET)

Study Details

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

Conditions

Abdominal Cancer

Pelvic Cancer

Study ID

NCT00493688

Start date

Oct 30, 2005

Status verified date

Jul, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiopulmonary Exercise Testing (CPET)

Interventions

Cardiopulmonary Exercise Testing (CPET)

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

Primary outcome measure

Patient Perioperative Risk [ Time Frame: Baseline + 30 days postoperatively monitoring for morbid events ]

Central Contacts and Locations

Central contacts

Anh Q Dang, MD

713-745-5025 adang@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

MD Anderson General Health Specialist

877-632-6789

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

Abdominal Cancer
Pelvic Cancer
Perioperative Energy Dynamics
Cardiopulmonary Exercise Testing
CPET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-15.