NCT00493688

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Cancer
• Pelvic Cancer

Interventions

Type	Name	Description
OTHER	Cardiopulmonary Exercise Testing (CPET)	Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.

Timeline

• Start date: 2005-10-30
• Primary completion: 2028-10-30
• Completion: 2028-10-30
• First posted: 2007-06-28
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States