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

NCT04024267 | Completed

• 1 other identifier: 123123
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in fatigue over the whole intervention

  Fatigue is measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). FACIT-F consists of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the fatigue subscale comprising 13 fatigue-related items, with a total of 41 items. The fatigue subscale score is ranging from 8 to 44. A score \< 34 is considered as cut-off for a diagnosis of relevant fatigue.

  End of the intervention (week 20)

Secondary Outcomes (6)

• Change from baseline in quality of life over the whole intervention

  End of the intervention (week 20)

• Change from baseline in patient's distress over the whole intervention

  End of the intervention (week 20)

• Change from baseline in sleep quality over the whole intervention

  End of the intervention (week 20)

• Change from baseline in pain over the whole intervention

  End of the intervention (week 20)

• Change from baseline in depression over the whole intervention

  End of the intervention (week 20)

Study Arms (2)

Eurythmy therapy (ERYT)

EXPERIMENTAL

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.

Other: Eurythmy therapy

CoordiFit

ACTIVE COMPARATOR

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.

Other: CoordiFit

Interventions

Eurythmy therapy OTHER

Mind-body therapy

Eurythmy therapy (ERYT)

CoordiFit OTHER

Fitness training

CoordiFit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (11)

Brustzentrum Basel Bethesda Spital

Basel, 4051, Switzerland

Location

St. Clara Forschung AG

Basel, 4058, Switzerland

Location

Engeriedspital

Bern, 3001, Switzerland

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Institute of Complementary and Integrative Medicine, University of Bern

Bern, 3012, Switzerland

Location

Hirslanden Bern AG, Salem-Spital, Brustzentrum Bern Biel

Bern, 3013, Switzerland

Location

Tumorzentrum ZeTuP Rapperswil-Jona

Rapperswil-Jona, 8640, Switzerland

Location

Tumor- und Brustzentrum ZeTuP AG

Sankt Gallen, 9006, Switzerland

Location

Kantonsspital St.Gallen, Zentrum für Integrative Medizin

Sankt Gallen, 9007, Switzerland

Location

Brustzentrum Ostschweiz AG

Sankt Gallen, 9016, Switzerland

Location

Kantonsspital Winterthur, Medizinische Onkologie und Hämatologie

Winterthur, 8401, Switzerland

Location

Related Publications (2)

• 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 Nov 11;30(11):oyaf343. doi: 10.1093/oncolo/oyaf343.

  PMID: 41123285 DERIVED

• 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.

  PMID: 32631427 DERIVED

MeSH Terms

Conditions

Fatigue; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ursula Wolf, Professor

  Institute for complementary and integrative medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: March 10, 2020
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (11)