Effectiveness of exercise therapy against fatigue (chronic fatigue) in patients with metastatic breast cancer.
Résumé de l'étude
In this study, 196 patients are randomly assigned to either the ERYT group (eurythmy therapy) or CoordiFit (gentle fitness training) (50% chance of being assigned to one group or the other). The exercise period lasts for each participant for 20 weeks, and two follow-ups (online questionnaires) are conducted after 6 and 12 months.
(BASEC)
Intervention étudiée
- In the ERYT group, mindful movement exercises are performed
- In the CoordiFit group, gentle fitness training is conducted
- The exercises are simple and can be learned without prior knowledge
- The exercises are tailored to the abilities and well-being of the patients
(BASEC)
Maladie en cours d'investigation
The study investigates whether exercise training is effective in patients with fatigue (chronic fatigue) related to metastatic breast cancer.
(BASEC)
All individuals suffering from fatigue related to metastatic breast cancer and over 18 years old can participate. (BASEC)
Critères d'exclusion
- Hemoglobin concentration < 9g/dl - Restrictions or contraindications that, according to the assessment of the study team, could hinder prolonged follow-up or the implementation of the active study interventions (BASEC)
Lieu de l’étude
Bâle, Berne, St-Gall, Winterthur, Autre
(BASEC)
Rapperswil-Jona
(BASEC)
Sponsor
Institute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Professor Ursula Wolf
+41 31 684 81 40
ursula.wolf@clutterunibe.chInstitute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Informations générales
Institute for complementary and integrative medicine
(ICTRP)
Informations scientifiques
Institute for complementary and integrative medicine
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
15.10.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT04024267 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: the ERYT/CoordiFit randomized controlled trial (BASEC)
Titre académique
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Titre public
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Maladie en cours d'investigation
FatigueBreast Cancer (ICTRP)
Intervention étudiée
Other: Eurythmy therapyOther: CoordiFit (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Female, aged 18 years or older
- Histologically or cytologically confirmed metastatic breast cancer
- FACIT-F subscale score < 34 (considered as cut-off for a diagnosis of relevant
fatigue a score < 30 is considered as severe fatigue [83])
- Eastern Cooperative Oncology Group (ECOG) grade 1 or 2
- Ability to physically and cognitively perform an active movement therapy
- Ability to provide informed consent as documented by signature
- Ability to read, write, and speak German, French, or Italian
Exclusion Criteria:
- Inability or contraindication that would prevent prolonged follow-up, or to undergo
the investigated intervention or control intervention, in the opinion of the
investigator
- Patients with psychiatric, addictive or any disorder that prevents the patient from
adhering to the protocol requirements, in the opinion of the investigator
- Significant uncontrolled cardiac disease (e.g. unstable angina, recent myocardial
infarction)
- Haemoglobin < 90 g/L (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Change from baseline in fatigue over the whole intervention (ICTRP)
Change from baseline in quality of life over the whole intervention;Change from baseline in patient's distress over the whole intervention;Change from baseline in sleep quality over the whole intervention;Change from baseline in pain over the whole intervention;Change from baseline in depression over the whole intervention;Change from baseline in anxiety over the whole intervention (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Breast Cancer Research Foundation (ICTRP)
Contacts supplémentaires
Ursula Wolf, Professor, Institute for complementary and integrative medicine (ICTRP)
ID secondaires
123123 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT04024267 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible