search
Back to results

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

Primary Purpose

Fatigue, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Eurythmy therapy
CoordiFit
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brustzentrum Basel Bethesda SpitalRecruiting
  • St. Clara Forschung AG
  • EngeriedspitalRecruiting
  • University Hospital BernRecruiting
  • Institute of Complementary and Integrative Medicine, University of BernRecruiting
  • Hirslanden Bern AG, Salem-Spital, Brustzentrum Bern BielRecruiting
  • Tumorzentrum ZeTuP Rapperswil-JonaRecruiting
  • Tumor- und Brustzentrum ZeTuP AGRecruiting
  • Kantonsspital St.Gallen, Zentrum für Integrative MedizinRecruiting
  • Brustzentrum Ostschweiz AGRecruiting
  • Kantonsspital Winterthur, Medizinische Onkologie und HämatologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eurythmy therapy (ERYT)

CoordiFit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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").
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.
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.

Full Information

First Posted
July 16, 2019
Last Updated
July 3, 2023
Sponsor
University of Bern
Collaborators
Breast Cancer Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04024267
Brief Title
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients
Acronym
ERYT
Official Title
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eurythmy therapy (ERYT)
Arm Type
Experimental
Arm Description
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.
Arm Title
CoordiFit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Eurythmy therapy
Intervention Description
Mind-body therapy
Intervention Type
Other
Intervention Name(s)
CoordiFit
Intervention Description
Fitness training
Primary Outcome Measure Information:
Title
Change from baseline in fatigue over the whole intervention
Description
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.
Time Frame
End of the intervention (week 20)
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life over the whole intervention
Description
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.
Time Frame
End of the intervention (week 20)
Title
Change from baseline in patient's distress over the whole intervention
Description
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.
Time Frame
End of the intervention (week 20)
Title
Change from baseline in sleep quality over the whole intervention
Description
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.
Time Frame
End of the intervention (week 20)
Title
Change from baseline in pain over the whole intervention
Description
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").
Time Frame
End of the intervention (week 20)
Title
Change from baseline in depression over the whole intervention
Description
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.
Time Frame
End of the intervention (week 20)
Title
Change from baseline in anxiety over the whole intervention
Description
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.
Time Frame
End of the intervention (week 20)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ursula Wolf, Professor
Phone
+41 (0)31 684 81 40
Email
ursula.wolf@unibe.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Eliane Timm, Dr
Phone
+41 (0)31 684 81 45
Email
eliane.timm@unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wolf, Professor
Organizational Affiliation
Institute for complementary and integrative medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Brustzentrum Basel Bethesda Spital
City
Basel
ZIP/Postal Code
4051
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathrin Balmelli, Dr. med.
Facility Name
St. Clara Forschung AG
City
Basel
ZIP/Postal Code
4058
Country
Switzerland
Individual Site Status
Terminated
Facility Name
Engeriedspital
City
Bern
ZIP/Postal Code
3001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Borner, Prof. Dr. med.
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Rabaglio, Dr. med.
Phone
031 632 70 43
Ext
+41
Email
manuela.rabaglio@insel.ch
Facility Name
Institute of Complementary and Integrative Medicine, University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula Wolf, Prof. Dr. med.
Facility Name
Hirslanden Bern AG, Salem-Spital, Brustzentrum Bern Biel
City
Bern
ZIP/Postal Code
3013
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Sager, Dr. med.
Facility Name
Tumorzentrum ZeTuP Rapperswil-Jona
City
Rapperswil-Jona
ZIP/Postal Code
8640
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Egger, Dr. med.
Facility Name
Tumor- und Brustzentrum ZeTuP AG
City
Saint Gallen
ZIP/Postal Code
9006
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Bolliger, Dr. med.
Facility Name
Kantonsspital St.Gallen, Zentrum für Integrative Medizin
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Schlaeppi, Dr. med.
Facility Name
Brustzentrum Ostschweiz AG
City
Saint Gallen
ZIP/Postal Code
9016
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrik Weder, Dr. med.
Facility Name
Kantonsspital Winterthur, Medizinische Onkologie und Hämatologie
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Müller, Dr. med.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32631427
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs