Suspendido

A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

educational intervention

+ supervised exercise program

Otro
Quiénes están siendo reclutados

Adenocarcinoma de pulmón+13

+ Carcinoma

+ Adenocarcinoma

Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Intervencional
Inicio del estudio: septiembre de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalSWOG Cancer Research Network
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de septiembre de 2004

Fecha en la que se inscribió al primer participante.

OBJECTIVES: * Compare improvement in physiologic function, in terms of exercise tolerance, in patients with inoperable locally advanced lung cancer undergoing chemoradiotherapy and randomized to pulmonary rehabilitation comprising education with vs without supervised exercise training. * Compare the health-related quality of life, in terms of multidimensional functioning and patient perception of respiratory difficulties, in patients undergoing these pulmonary rehabilitation interventions. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0-1 vs 2); FEV\_1 (≥ 70% of predicted vs < 70% of predicted); and smoking status\* (never smoked or former smoker vs current smoker). Approximately 20 weeks into treatment on SWOG-S0023, patients are randomized to 1 of 2 intervention arms. NOTE: \* Never smoked is defined as < 100 cigarettes in a lifetime and former smoker is defined as no smoking for ≥ 1 year. * Arm I: Patients participate in a supervised structured exercise program (i.e., walking on a treadmill OR using a stationary exercise bicycle) 3 times a week for 12 weeks. Patients also receive educational materials on how to improve breathing and conserve energy. * Arm II: Patients receive educational materials as in arm I. In both arms, patients undergo exercise testing using 6-minute walks to measure exercise tolerance at initial evaluation (after randomization but prior to intervention), 12 weeks, and then at 6 and 9 months. In both arms, intervention continues in the absence of disease progression or the development of other medical conditions that would preclude study participation. Quality of life is assessed at baseline, 12 weeks, and then at 6 and 9 months. PROJECTED ACCRUAL: A total of 164 patients (82 per treatment arm) will be accrued for this study.

Título OficialA Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
NCT00090961
Patrocinador PrincipalSWOG Cancer Research Network
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 2 pacientes

Número total de participantes que el ensayo clínico espera reclutar.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Adenocarcinoma de pulmónCarcinomaAdenocarcinomaCarcinoma de pulmón no microcíticoCarcinoma broncogénicoAdenocarcinoma bronquio-alveolarNeoplasias bronquialesEnfermedades del pulmónNeoplasmas PulmonaresNeoplasiasNeoplasias por SitioNeoplasias por tipo histológicoNeoplasias glandulares y epitelialesNeoplasias del tracto respiratorioEnfermedades del Tracto RespiratorioNeoplasias torácicas

Criterios

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed single, primary bronchogenic lung cancer * Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB disease) * The following histologies are eligible: * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Non-lobar and non-diffuse bronchoalveolar carcinoma * Small cell lung cancer * Must have received chemotherapy (platinum based) and radiotherapy for locally advanced unresectable lung cancer * Must have achieved a complete response, partial response, or stable disease after treatment PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude study participation * No uncontrolled cardiac disease * No recent myocardial infarction Pulmonary * Any FEV\_1 level by pulmonary function testing Other * Willing to participate in 12-week long exercise program * Chemotherapy-induced neuropathy ≤ grade 2 * No uncontrolled diabetes mellitus * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
A 12-week supervised exercise program consisting of 3 days a week on a stationary bike or treadmill. In addition, at the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Grupo II

At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 59 ubicaciones

Suspendido

Poudre Valley Hospital

Fort Collins, United StatesAbrir Poudre Valley Hospital en Google Maps
Suspendido

Decatur Memorial Hospital Cancer Care Institute

Decatur, United States
Suspendido

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, United States
Suspendido

Regional Cancer Center at Memorial Medical Center

Springfield, United States
Suspendido59 Centros de Estudio