RecruitingNot ApplicableNCT04457895

Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

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.


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

108 participants

Start Date

Feb 11, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a program combining physical therapy, yoga, and patient education can reduce joint and muscle pain caused by hormone therapy in breast cancer patients. Hormone therapy (used to prevent cancer recurrence) commonly causes pain, and this study explores non-medication ways to manage it. **You may be eligible if:** - You are 18 or older with non-metastatic breast cancer - You are currently taking hormone therapy and the dosage has been stable for at least 30 days - You experience joint or muscle pain rated 4 or higher out of 10 that is caused by your hormone therapy - Your previous cancer treatments (surgery, chemo, or radiation) ended at least 2 months ago **You may NOT be eligible if:** - You have chronic rheumatological pain requiring specialized care - You have practiced yoga regularly in the past 3 months - You have a physical condition that prevents exercise - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALeducational 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)

OTHERno 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, New Aquitaine, France

Institut du sein Basque

Tosse, New Aquitaine, France

Institut de Cancérologie de l'Ouest

Angers, Pays de la Loire Region, France

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NCT04457895


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