Abdominal Cancer, Pelvic Cancer
Conditions
Keywords
Abdominal Cancer, Pelvic Cancer, Perioperative Energy Dynamics, Cardiopulmonary Exercise Testing, CPET
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.
Interventions
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perioperative Risk | 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 |
Countries
United States
Contacts
Primary ContactAnh Q Dang, MD
Outcome results
None listed