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FatigueERYTNCT04024267

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

A study testing Eurythmy therapy and CoordiFit in people with Fatigue and Breast Cancer, run by University of Bern at 11 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fatigue, Breast Cancer
What is being tested?
Eurythmy therapy and CoordiFit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
11 sitesSwitzerland
Study dates
10 Mar 2020to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Switzerland11 sites

  • Brustzentrum Basel Bethesda Spital

    Basel, 4051

  • St. Clara Forschung AG

    Basel, 4058

  • Engeriedspital

    Bern, 3001

  • University Hospital Bern

    Bern, 3010

  • Institute of Complementary and Integrative Medicine, University of Bern

    Bern, 3012

  • Hirslanden Bern AG, Salem-Spital, Brustzentrum Bern Biel

    Bern, 3013

  • Tumorzentrum ZeTuP Rapperswil-Jona

    Rapperswil-Jona, 8640

  • Tumor- und Brustzentrum ZeTuP AG

    Sankt Gallen, 9006

  • Kantonsspital St.Gallen, Zentrum für Integrative Medizin

    Sankt Gallen, 9007

  • Brustzentrum Ostschweiz AG

    Sankt Gallen, 9016

  • Kantonsspital Winterthur, Medizinische Onkologie und Hämatologie

    Winterthur, 8401

Other trials in Switzerland

About this study

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.

Being tested
Eurythmy therapy, CoordiFit
Medical subject headings
Fatigue, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eurythmy therapyOther

    Mind-body therapy

  • CoordiFitOther

    Fitness training

Study groups in NCT04024267
Study groupRoleWhat they receive
Eurythmy therapy (ERYT)ExperimentalEurythmy 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.
Receives: Other: Eurythmy therapy
CoordiFitActive comparatorThe 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.
Receives: Other: CoordiFit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: End of the intervention (week 20)

Secondary outcomes (6)

  1. Change from baseline in quality of life over the whole intervention

    Quality of life 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 FACT-G subscale score ranges from 0 to 108. The higher the FACT-G subscale score the better the quality of life.

    Measured: End of the intervention (week 20)

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

    Patient's distress is measured using the National Comprehensive Cancer Network (NCCN) Distress thermometer. The NCCN Distress thermometer ranges from 0 to 10, with 10 indicating an extreme distress and 0 indicating no distress.

    Measured: End of the intervention (week 20)

  3. Change from baseline in sleep quality over the whole intervention

    Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score of the 9 items ranges from 0 to 21. A score < or = 5 is associated with good sleep quality; a score > 5 is associated with poor sleep quality.

    Measured: End of the intervention (week 20)

  4. Change from baseline in pain over the whole intervention

    Pain is measured using the Brief Pain Inventory (BPI). The BPI assesses pain at its "worst", "least", "average", and "now" (current pain). The four severity items range from 0 ("no pain") to 10 ("pain as bad as you can imagine").

    Measured: End of the intervention (week 20)

  5. Change from baseline in depression over the whole intervention

    Depression is assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively.

    Measured: End of the intervention (week 20)

  6. Change from baseline in anxiety over the whole intervention

    Anxiety disorders are assessed using the General Anxiety Disorder-7 (GAD-7). The GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively.

    Measured: End of the intervention (week 20)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start10 Mar 2020
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04024267
Sponsor's protocol ID
123123
Acronym
ERYT
Status last verified
Aug 2025
First submitted
16 Jul 2019
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41123285

  • 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.

    PubMed 32631427

Questions about this trial

What is this clinical trial studying?

A study testing Eurythmy therapy and CoordiFit in people with Fatigue and Breast Cancer, run by University of Bern at 11 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in fatigue over the whole intervention (time frame: End of the intervention (week 20)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024267, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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