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Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Summary
As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment. Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga. It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves. The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising. The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain. Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.
Official title: A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
Key Details
Gender
FEMALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2021-02-11
Completion Date
2028-08
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
educational yoga program
Daily 15-min yoga sessions at home with the "Le guide du yoga" and the audio-guide, during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yog (the first on site and by videoconference for the others)
no intervention
no yoga session at home and no yoga -therapeutic educatuion session
Locations (7)
CH Libourne
Libourne, Aquitaine, France
Icm Val D'Aurelle
Montpellier, Herault, France
CHU Nîmes
Nîmes, Herault, France
Insitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France
Institut Bergonié
Bordeaux, Nouvelle-Aquitaine, France
Institut du sein Basque
Tosse, Nouvelle-Aquitaine, France
Institut de Cancérologie de l'Ouest
Angers, Pays de la Loire Region, France