- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01893580
Perioperative Rehabilitation in Operation for Lung Cancer (PROLUCA)
Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.
Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.
Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.
What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.
- Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
- The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.
What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).
Will all participants receive the same treatment?
By draw it is decided which of the 4 groups the participants will attend to in the study:
- Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
- Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
- Group 3: Rehabilitation initiated as early as two weeks after surgery
- Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nørrebro
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Copenhagen, Nørrebro, Dinamarca, DK-2200
- Copenhagen Centre for Cancer and Health
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Performance status 0-2 (WHO)
- Living in the City of Copenhagen or surrounding Municipalities
- Ability to read and understand Danish
- Approval by primary surgeon
Exclusion Criteria:
- Presence of metastatic disease or surgical inoperability
- Diagnosis of Lung Cancer not verified by histological diagnosis
- Cardiac disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.
|
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:
Otros nombres:
|
Experimental: 2. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery.
|
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:
Otros nombres:
|
Experimental: 3. Experimental
Exercise in a team initiated two weeks after surgery.
|
Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of: Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
Otros nombres:
|
Otro: 4. Usual care
Exercise in a team initiated six weeks after surgery.
|
Exercise in a team initiated six weeks after surgery consisting of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum oxygen uptake (VO2peak)
Periodo de tiempo: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
|
VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©).
Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©).
Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.).
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VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Six minute walk distance (6MWD)
Periodo de tiempo: baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
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baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
|
|
Patient reported outcomes (PROs)
Periodo de tiempo: Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
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PROs will include health related quality of life, symptoms and side-effects, anxiety and depression, well-being, distress, lifestyle, sickness absence, work status, and social support.
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Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
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Pulmonary function
Periodo de tiempo: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
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forced expiratory volume at one second
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Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Jesper Holst Pedersen, MD, DrMSci, Department of Cardiothoracic Surgery RT
- Director de estudio: Jette Vibe-Petersen, MD, Copenhagen Centre for Cancer and Health
- Investigador principal: Maja Schick Sommer, MHS, Copenhagen Centre for Cancer and Health
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROLUCA
- 2007-58-0015 (Danish Data Protection Agency)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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