Effectiveness of exercise therapy against fatigue (chronic fatigue) in patients with metastatic breast cancer.
Summary description of the study
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 under investigation
- 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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Basel, Bern, St. Gallen, Winterthur, Other
(BASEC)
Rapperswil-Jona
(BASEC)
Sponsor
Institute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Contact
Contact Person Switzerland
Professor Ursula Wolf
+41 31 684 81 40
ursula.wolf@clutterunibe.chInstitute of Complementary and Integrative Medicine, University of Bern
(BASEC)
General Information
Institute for complementary and integrative medicine
(ICTRP)
Scientific Information
Institute for complementary and integrative medicine
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
15.10.2019
(BASEC)
ICTRP Trial ID
NCT04024267 (ICTRP)
Official title (approved by ethics committee)
Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: the ERYT/CoordiFit randomized controlled trial (BASEC)
Academic title
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Public title
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Disease under investigation
FatigueBreast Cancer (ICTRP)
Intervention under investigation
Other: Eurythmy therapyOther: CoordiFit (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Breast Cancer Research Foundation (ICTRP)
Additional contacts
Ursula Wolf, Professor, Institute for complementary and integrative medicine (ICTRP)
Secondary trial IDs
123123 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT04024267 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available