Protocol Study protocol: Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients [...], 2020, Wolf et al

From @MSEsperanza:

Abstract

Background

Cancer-related fatigue (CRF) is the most taxing symptom for many breast cancer patients during and after therapy. In patients with metastatic disease, the prevalence of CRF exceeds 75%. Currently, there is no gold standard for the treatment of CRF. Physical activity can reduce CRF and is recommended during and after cancer treatment, but may be too burdensome for patients with metastatic breast cancer. The aim of this study is to assess the effect on fatigue of eurythmy therapy (ERYT) compared to slow movement fitness (CoordiFit) in metastatic breast cancer patients.

Methods

The ERYT/CoordiFit study is a randomized controlled, open-label, two-arm, multi-center Swiss clinical trial. A sample of 196 patients presenting with CRF will be recruited by oncologists from the departments of clinical oncology at each local study site. All participants will be randomly allocated to the intervention or control group in a 1:1 ratio. The control group is an active control intervention (CoordiFit) in order to control for potential non-intended effects such as therapist-patient interaction and participation in a program. Both ERYT and CoordiFit exercises are easy to learn, and the training sessions will follow the same frequency and duration schedule, i.e., 13 standardized therapy sessions of 45 min (once a week for 6 weeks and then once every second week) during the total intervention period of 20 weeks. The primary endpoint of the study is the change from baseline over the whole intervention period (i.e., including measurements at baseline, weeks 8, 14, and 20) in the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) subscale score.

Discussion

This study is the first-known randomized clinical trial assessing eurythmy therapy in the treatment of fatigue in metastatic breast cancer patients. Given the distress that fatigue causes patients, it is important to validate treatment options. If eurythmy therapy proves beneficial in CRF as part of this randomized controlled clinical trial, the study may be very impactful with implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists, and funding and regulatory bodies.


Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336433/

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. PMID: 32631427; PMCID: PMC7336433.

Registered at the US National Institutes of Health (ClinicalTrials.gov) :

https://clinicaltrials.gov/study/NCT04024267?tab=table

 

Follow-up post from @MSEsperanza:

Don't want to endorse healthcare based on pseudoscience ('anthroposophic medicine'), but thought it could be interesting that / what objective outcome measures are used in this trial -- when I last checked I couldn't find a trial on behavioral/ exercise/ physical therapy interventions for cancer related fatigue that used objective outcomes.

So here secondary outcome measures at least include return to work. Also "targeted metabolomics" but only in 30 patients and I don't have the expertise to judge whether they make sense at all:

"Analysis of amino acids, organic acid profiles, and acylcarnitine profiles in serum and urine will be measured with high-performance liquid chromatography and liquid chromatography-mass spectrometry, allowing for analysis of over 100 metabolites. Metabolomic data will be measured at baseline and at the end of intervention (week 20)."

 

I don't think I'm being cynical in saying is this another niche of patients they've found who are too exhausted (and have too many other priorities) to 'pick a fight' with someone deluded and determined that their thing works by not 'being a belieber'

 

My understanding is that these tests could be useful for genetic disorders and not much else? Otherwise it will set you back a few hundred $$ like it did for me.