Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer

Официальное название

Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer

Обзор

This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia, unplanned intubations, difficulty breathing and reduced physical functioning, and increased medical costs and a reduced quality of life. Improving pre-surgical pulmonary health through respiratory muscle training may improve respiratory muscle strength, response to surgery, and quality of life after surgery in patients with lung cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. Assess the impact of a short-duration respiratory muscle training (RMT) program on respiratory muscle strength in patients undergoing resection for lung cancer.

SECONDARY OBJECTIVES:

I. Compare the extent of diaphragm atrophy and catabolic/anabolic pathway activation between RMT responders and non-responders evaluated for gene expression and candidate and candidate causative protein levels.

II. Determine the effect of the short-duration RMT program on health related quality-of-life measures.

III. Assess the impact of the short-duration RMT program on postoperative outcomes.

EXPLORATORY OBJECTIVES:

I. Determine the financial sustainability of a transitional home-based prehabilitation program targeting respiratory muscle weakness prior to lung resection.

II. Analysis of molecular markers to correlate with patient outcome and potentially differentiate responders from non-responders.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (USUAL CARE): Patients receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery.

ARM II (RMT + USUAL CARE): Patients use a power lung device to complete 3 sets of 15 RMT exercises over 30 minutes 6 days per week over 2-4 weeks for a minimum of 12 sessions prior to surgery. Patients also receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery.

After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Вмешательства

• Другое Best Practice
  Receive usual care
• Процедура Laparoscopic Surgery
  Undergo laparoscopic surgery
• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies
• Устройство Respiratory Muscle Training Device
  Use power lung device to complete RMT
• Процедура Video-Assisted Thoracic Surgery
  Undergo video-assisted thoracic surgery

Первичные конечные точки

• Change in inspiratory and expiratory muscle strength [Срок оценки: Baseline up to 12 months]
• Change in pulmonary function and respiratory muscle endurance [Срок оценки: Baseline up to 12 months]
• Change in peak exercise capacity (VO2peak) [Срок оценки: Baseline up to 12 months]

Вторичные конечные точки (11)

• Metabolic and muscle physiology marker analysis [Срок оценки: At time of surgical resection]
• Gene expression ribonucleic acid (RNA) extraction, reverse transcription, and real-time quantitative polymerase chain reaction (PCR) analysis [Срок оценки: At time of surgical resection]
• Change in quality of life (QoL) [Срок оценки: Baseline up to 12 months]
• Change in QoL [Срок оценки: Baseline up to 12 months]
• Change in fatigue level [Срок оценки: Baseline up to 12 months]
• Change in sleepiness (sleep apnea) [Срок оценки: Baseline up to 12 months]
• Change in sleepiness (sleep apnea) [Срок оценки: Baseline up to 12 months]
• Change in sleep quality [Срок оценки: Baseline up to 12 months]
• Change in anxiety and depression [Срок оценки: Baseline up to 12 months]
• Change in dyspnea [Срок оценки: Baseline up to 12 months]
• Presence or absence of pneumonia diagnoses [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• Documented stage I-IIIb lung cancer or is undergoing surgery for diagnosis
• Participant is able to speak, read, and comprehend English
• Participant must be undergoing or is anticipated to either video-assisted thoracic surgery (VATS or robotic surgery) or laparoscopic surgery for curative intent lung resection
• Patients with or without neoadjuvant chemoradiotherapy (CRT) prior to surgery will be included
• Ability to follow written and verbal instructions
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Критерии исключения

• Documented ischemic heart disease; congestive heart failure or; significant cardiac arrhythmias that would exclude them from having surgery
• Overall medical frailty (clinician discretion) or ECOG > 2
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in this study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

NCT: NCT04067830 · I 72818 · NCI-2019-03537 · I 72818 · R01CA222382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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