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RECRUITING
NCT04457895
NA

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

View on ClinicalTrials.gov

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

BEHAVIORAL

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)

OTHER

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