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Clinical Trial NCT00493688 for Abdominal Cancer, Pelvic Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

Recruiting
Clinical Trial NCT00493688 is an observational study for Abdominal Cancer, Pelvic Cancer that is recruiting. It started on October 30, 2005 with plans to enroll 200 participants. Led by M.D. Anderson Cancer Center, it is expected to complete by October 30, 2025. The latest data from ClinicalTrials.gov was last updated on August 1, 2025.
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
Detailed 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.

Official Title

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

Conditions
Abdominal CancerPelvic Cancer
Other Study IDs
  • 2005-0303
  • NCI-2024-06349 (Other Identifier) (Clinicl Trials Reporting Program (CTRP))
NCT ID Number
NCT00493688
Start Date (Actual)
2005-10-30
Last Update Posted
2025-08-01
Completion Date (Estimated)
2025-10-30
Enrollment (Estimated)
200
Study Type
Observational
Status
Recruiting
Keywords
Abdominal Cancer
Pelvic Cancer
Perioperative Energy Dynamics
Cardiopulmonary Exercise Testing
CPET
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Cardiopulmonary Exercise Testing (CPET)
Cardiopulmonary Exercise Testing (CPET)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
M.D. Anderson Cancer Center logoM.D. Anderson Cancer Center1128 active trials to explore
Study Central Contact
Contact: Anh Q Dang, MD, 713-745-5025, [email protected]
1 Study Locations in 1 Countries

Texas

University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States
MD Anderson General Health Specialist, Contact, 877-632-6789
Recruiting