Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients

NCT ID: NCT04024267

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2025-07-31

Brief Summary

Cancer related fatigue (CRF) is the most burdening symptom in breast cancer patients, and prevalence exceeds 75% in patients with metastatic disease. CRF is described as the symptom that has the largest impact on quality of life, with negative effects on work, social activities, and daily activities, and may lead to treatment discontinuation. Currently, there is no gold standard for the treatment of CRF. Drug therapies are not satisfactory. Since physical activity is associated with significant reduction in CRF, patients are encouraged to engage in an at least moderate level of physical activity. However, for many metastatic breast cancer patients this is too burdensome. Finally, there is some evidence that non-pharmacological mind-body techniques may be beneficial in reducing CRF, yet the available data do not allow for final recommendations. Given the high prevalence of CRF and the substantial distress for patients, advancing treatment options for patients with CRF is highly desirable. In the present study, patients with metastatic breast cancer will be randomly assigned to two different non-pharmacological treatments for fatigue: Eurythmy therapy (ERYT), a standardized active mindful movement therapy, or a movement program without mindfulness features (CoordiFit). It will be tested, if ERYT has a superior benefit on fatigue compared to CoordiFit over the period of the intervention (20 weeks). Further, the benefit of ERYT on quality of life, sleep quality, anxiety, depression, pain, mobility of the arm, rate of return to work, compliance with ERYT, and targeted metabolomics will be investigated.

Both groups will have equal frequency and duration of the training sessions. Each patient will receive 13 standardized therapy sessions of 45 min (once a week for 6 weeks and once every second week) during the total period of 20 weeks. The proposed study has been developed in the Breast Cancer Project Group of the Swiss Group for Clinical Cancer Research (SAKK) and is supported by many breast centers, because they realize that the patients value non-pharmacological treatment options and would be keen to participate in such a trial. If ERYT proves to be beneficial, the impact of this trial will be high and will have implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists and funding and regulatory bodies.

Conditions

Fatigue; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Eurythmy therapy (ERYT)

Eurythmy therapy (ERYT) is a standardized movement therapy and for each medical condition standardized ERYT exercise (series) exist. In such, in the present study, the cancer series "O-E-M-L-I-B-D" that is specific and standardized for breast cancer patients will be applied. Patients can perform and maintain the postures without stress and tension. Patients are instructed by ERYT therapists in sessions with 1 to 4 patients.

Group Type: EXPERIMENTAL

Eurythmy therapy

Intervention Type: OTHER

Mind-body therapy

CoordiFit

The CoordiFit program consists of standardized exercises that address physical coordination, stability, balance and dexterity. These exercises serve as a control intervention and are non-specific with respect of cancer-related fatigue and breast cancer. They mimic those of ERYT but have no mindfulness features. Patients are instructed by physical therapists in session with 1 to 4 patients.

Group Type: ACTIVE_COMPARATOR

CoordiFit

Intervention Type: OTHER

Fitness training

Interventions

Eurythmy therapy

Mind-body therapy

Intervention Type: OTHER

CoordiFit

Fitness training

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ursula Wolf, Professor

Role: STUDY_CHAIR

Institute for complementary and integrative medicine

Locations

Brustzentrum Basel Bethesda Spital

Basel, , Switzerland

St. Clara Forschung AG

Basel, , Switzerland

Engeriedspital

Bern, , Switzerland

University Hospital Bern

Bern, , Switzerland

Institute of Complementary and Integrative Medicine, University of Bern

Bern, , Switzerland

Hirslanden Bern AG, Salem-Spital, Brustzentrum Bern Biel

Bern, , Switzerland

Tumorzentrum ZeTuP Rapperswil-Jona

Rapperswil-Jona, , Switzerland

Tumor- und Brustzentrum ZeTuP AG

Sankt Gallen, , Switzerland

Kantonsspital St.Gallen, Zentrum für Integrative Medizin

Sankt Gallen, , Switzerland

Brustzentrum Ostschweiz AG

Sankt Gallen, , Switzerland

Kantonsspital Winterthur, Medizinische Onkologie und Hämatologie

Winterthur, , Switzerland

Countries

Switzerland

References

Timm E, Berlowitz I, Wolf U. Randomized controlled trial on eurythmy therapy versus slow-paced physical exercises for the treatment of fatigue in metastatic breast cancer patients. Oncologist. 2025 Oct 22:oyaf343. doi: 10.1093/oncolo/oyaf343. Online ahead of print.

Reference Type: DERIVED

PMID: 41123285 (View on PubMed)

Meier-Girard D, Ribi K, Gerstenberg G, Ruhstaller T, Wolf U. Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial. Trials. 2020 Jul 6;21(1):612. doi: 10.1186/s13063-020-04542-5.

Reference Type: DERIVED

PMID: 32631427 (View on PubMed)

Other Identifiers

123123

Identifier Type: -

Identifier Source: org_study_id