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SNCTP000003525 | NCT04024267 | BASEC2019-01455

Wirksamkeit von Bewegungstherapie gegen Fatigue (chronische Müdigkeit) bei Patientinnen mit metastasierter Brustkrebserkrankung.

Data source: BASEC (Imported from 19.10.2021), WHO (Imported from 18.04.2021)
Changed: 09.08.2021
Disease category: Breast Cancer

Brief description of trial (Data source: BASEC)

In dieser Studie werden 196 Patientinnen entweder der Gruppe ERYT (Eurythmietherapie) oder CoordiFit (sanftes Fitnesstraining) nach dem Zufallsprinzip zugeteilt (je 50% Chance der einen oder anderen Gruppe zugeteilt zu werden). Die Übungsperiode dauert für die einzelne Teilnehmerin 20 Wochen, und zwei Nachbeobachtungen (online Fragebögen) erfolgen nach 6 und 12 Monaten.

Health conditions investigated (Data source: BASEC)

Die Studie untersucht, ob Bewegungstraining bei Patientinnen mit Fatigue (chronische Müdigkeit) bei metastasierter Brustkrebserkrankung wirksam ist.

Health conditions (Data source: WHO)

Fatigue;Breast Cancer

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

- In der ERYT-Gruppe werden achtsame Bewegungsübungen durchgeführt
- In der CoordiFit-Gruppe wird ein sanftes Fitnesstraining durchgeführt
- Die Übungen sind einfach und ohne Vorkenntnisse zu erlernen
- Die Übungen werden den Fähigkeiten und dem Befinden der Patientinnen angepasst

Interventions (Data source: WHO)

Other: Eurythmy therapy;Other: CoordiFit

Criteria for participation in trial (Data source: BASEC)

Es können alle Personen teilnehmen, die unter Fatigue bei metastasiertem Brustkrebserkrankung leiden und über 18 Jahre alt sind.

Exclusion criteria (Data source: BASEC)

- Hämoglobinkonzentration < 9g/dl
- Einschränkungen oder Kontraindikationen (Gegenanzeigen), die gemäss der Einschätzung der Studienleitung, einer verlängerte Nachbeobachtung oder der Durchführung der aktiven Studieninterventionen entgegenstehen könnten

Inclusion/Exclusion Criteria (Data source: WHO)


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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04024267

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04024267

Further information on trial

Date trial registered

16.07.2019

Incorporation of the first participant

10.03.2020

Recruitment status

Recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Change from baseline in fatigue over the whole intervention

Secundary end point (Data source: WHO)

Change from baseline in quality of life over the whole intervention;Change from baseline in patient's distress over the whole intervention;Change from baseline in sleep quality over the whole intervention;Change from baseline in pain over the whole intervention;Change from baseline in depression over the whole intervention;Change from baseline in anxiety over the whole intervention

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Bern, La Chaux-de-Fonds, Neuchatel, Rapperswil-Jona, St. Gallen, Winterthur

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Professor Ursula Wolf
+41 31 631 81 40
ursula.wolf@ikim.unibe.ch

Contact for general information (Data source: WHO)

Ursula Wolf, Professor
Institute for complementary and integrative medicine
+41 (0)31 631 81 40
ursula.wolf@ikim.unibe.ch

Contact for scientific information (Data source: WHO)

Ursula Wolf, Professor
Institute for complementary and integrative medicine
+41 (0)31 631 81 40
ursula.wolf@ikim.unibe.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

University of Bern

Additional sponsors (Data source: WHO)

Breast Cancer Research Foundation

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

15.10.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-01455

Secondary ID (Data source: WHO)

123123