A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
educational intervention
+ supervised exercise program
Adénocarcinome du poumon+13
+ Adénocarcinome
+ Néoplasmes bronchiques
Résumé
Date de début de l'étude : 1 septembre 2004
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.2 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 59 sites
Decatur Memorial Hospital Cancer Care Institute
Decatur, United StatesCardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, United StatesRegional Cancer Center at Memorial Medical Center
Springfield, United States