Effectiveness of exercise therapy against fatigue (chronic fatigue) in patients with metastatic breast cancer.
Descrizione riassuntiva dello studio
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)
Intervento studiato
- 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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Basilea, Berna, San Gallo, Winterthur, Altro
(BASEC)
Rapperswil-Jona
(BASEC)
Sponsor
Institute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Professor Ursula Wolf
+41 31 684 81 40
ursula.wolf@clutterunibe.chInstitute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Informazioni generali
Institute for complementary and integrative medicine
(ICTRP)
Informazioni scientifiche
Institute for complementary and integrative medicine
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
15.10.2019
(BASEC)
ID di studio ICTRP
NCT04024267 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: the ERYT/CoordiFit randomized controlled trial (BASEC)
Titolo accademico
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Titolo pubblico
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Malattie studiate
FatigueBreast Cancer (ICTRP)
Intervento studiato
Other: Eurythmy therapyOther: CoordiFit (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Breast Cancer Research Foundation (ICTRP)
Contatti aggiuntivi
Ursula Wolf, Professor, Institute for complementary and integrative medicine (ICTRP)
ID secondari
123123 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT04024267 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile