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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Patient Perioperative Risk [Срок оценки: Baseline + 30 days postoperatively monitoring for morbid events]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Texas MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT00493688 · 2005-0303 · NCI-2024-06349

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗