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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-30

Study Completion Date

2028-10-30

Brief Summary

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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

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Detailed Description

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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

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Abdominal Cancer Pelvic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiopulmonary Exercise Testing (CPET)

Intervention Type OTHER

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

Interventions

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Cardiopulmonary Exercise Testing (CPET)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No