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

Abdominal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00493688
• Other study ID #: 2005-0303
• Status: Recruiting
• Start date: October 30, 2005
• Est. completion date: October 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Anh Q Dang, MD
• Phone: 713-745-5025
• Email: adang[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Abdominal Cancer
• Pelvic Cancer
• Pelvic Neoplasms

Intervention

Other:
• Cardiopulmonary Exercise Testing (CPET)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Perioperative Risk	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	Baseline + 30 days postoperatively monitoring for morbid events

External Links

•   University of Texas MD Anderson Cancer Center Website