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O estudo clínico NCT00493688 para Câncer abdominal, Câncer pélvico está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

Recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT00493688 é um ensaio observacional para Câncer abdominal, Câncer pélvico. Seu status atual é: recrutando. O estudo começou em 30 de outubro de 2005 e pretende incluir 200 participantes. Coordenado por o Centro de Câncer MD Anderson e deve ser concluído em 30 de outubro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 1 de agosto de 2025.
Resumo

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
Descrição detalhada
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.

Título oficial

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

Condições
Câncer abdominalCâncer pélvico
Outros IDs do estudo
  • 2005-0303
  • NCI-2024-06349 (Outro identificador) (Clinicl Trials Reporting Program (CTRP))
Número NCT
NCT00493688
Data de início (real)
2005-10-30
Última atualização postada
2025-08-01
Data de conclusão (estimada)
2025-10-30
Inscrição (estimada)
200
Tipo de estudo
Observacional
Status
Recrutando
Palavras-chave
Abdominal Cancer
Pelvic Cancer
Perioperative Energy Dynamics
Cardiopulmonary Exercise Testing
CPET
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Cardiopulmonary Exercise Testing (CPET)
Teste de exercício cardiopulmonar (TECP)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 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 logoCentro de Câncer MD Anderson1128 estudos clínicos ativos para explorar
Contato central do estudo
Contato: Anh Q Dang, MD, 713-745-5025, [email protected]
1 Locais do estudo em 1 países

Texas

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