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Perioperative Rehabilitation in Operation for Lung Cancer (PROLUCA)

5 mai 2015 mis à jour par: Jesper Holst Pedersen, Rigshospitalet, Denmark

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.

  1. 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.
  2. 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Danemark
    • Nørrebro
      • Copenhagen, Nørrebro, Danemark, DK-2200
        • Copenhagen Centre for Cancer and Health

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.
Comportemental: Experimental: 1. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

  1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
  2. 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.
Autres noms:
  • Preoperative and early postoperative rehabilitation
Expérimental: 2. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery.
Comportemental: Experimental: 2. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:

  1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
  2. 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.
Autres noms:
  • Preoperative and late postoperative rehabilitation
Expérimental: 3. Experimental
Exercise in a team initiated two weeks after surgery.
Comportemental: Experimental: 3. Experimental

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.

Autres noms:
  • Early postoperative rehabilitation alone
Autre: 4. Usual care
Exercise in a team initiated six weeks after surgery.
Comportemental: Other: 4. Usual care

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.

Autres noms:
  • Soins habituels

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Maximum oxygen uptake (VO2peak)
Délai: 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.).
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Six minute walk distance (6MWD)
Délai: 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.
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)
Délai: 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.
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.
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.
Pulmonary function
Délai: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
forced expiratory volume at one second
Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Rigshospitalet, Denmark

Collaborateurs

Novo Nordisk A/S
University of Copenhagen
Danish Cancer Society
Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark
Copenhagen Centre for Cancer and Health, Denmark.

Les enquêteurs

  • Chaise d'étude: Jesper Holst Pedersen, MD, DrMSci, Department of Cardiothoracic Surgery RT
  • Directeur d'études: Jette Vibe-Petersen, MD, Copenhagen Centre for Cancer and Health
  • Chercheur principal: Maja Schick Sommer, MHS, Copenhagen Centre for Cancer and Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2012

Achèvement primaire (Réel)

1 octobre 2014

Achèvement de l'étude (Réel)

1 janvier 2015

Dates d'inscription aux études

Première soumission

20 juin 2013

Première soumission répondant aux critères de contrôle qualité

2 juillet 2013

Première publication (Estimation)

9 juillet 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

7 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2015

Dernière vérification

1 mai 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PROLUCA
  • 2007-58-0015 (Danish Data Protection Agency)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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