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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04024267

Studienbeginn:
März 2020

Letztes Update:
10.12.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms, Fatigue

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Bern

Collaborator:
Breast Cancer Research Foundation

Studienleiter

Ursula Wolf, Professor
Study Chair
Institute for complementary and integrative medicine

Kontakt

Studienlocations (3 von 5)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change from baseline in fatigue over the whole intervention (Time Frame - End of the intervention (week 20)):
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:

1. Change from baseline in quality of life over the whole intervention (Time Frame - End of the intervention (week 20)):
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.

2. Change from baseline in patient's distress over the whole intervention (Time Frame - End of the intervention (week 20)):
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.

3. Change from baseline in sleep quality over the whole intervention (Time Frame - End of the intervention (week 20)):
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.

4. Change from baseline in pain over the whole intervention (Time Frame - End of the intervention (week 20)):
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").

5. Change from baseline in depression over the whole intervention (Time Frame - End of the intervention (week 20)):
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.

6. Change from baseline in anxiety over the whole intervention (Time Frame - End of the intervention (week 20)):
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.

Studien-Arme

  • Experimental: 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.
  • Active Comparator: 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.

Geprüfte Regime

  • Eurythmy therapy:
    Mind-body therapy
  • CoordiFit:
    Fitness training

Quelle: ClinicalTrials.gov


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