About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Non metastatic breast cancer
Ongoing hormone therapy, with no treatment modification in the 30 days before inclusion
Osteoarticular and/or musculoskeletal pain due to HT ≥ 4 on the Numeric Pain Rating Scale (NPRS)
Disqualifiers
Chronic rhumatologic pain with specific care needed
Regular Yoga practice in the 3 months before inclusion
Contraindication or clinical state not allowing physical practice
Patient whose regular follow-up is initially impossible for psychological, family, social or geographical reasons,
Trial design
Parallel
Treatments tested in this trial
educational yoga program
BehavioralDaily 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
Other interventionno yoga session at home and no yoga -therapeutic educatuion session
Treatment groups
Trial outcomes
Primary outcomes
the efficacy of a combined intervention of physical therapy and yoga, including patient education with a control group for confirmed osteoarticular and/or musculoskeletal pain (≥4) due to hormone therapy in patients treated for breast cancer.
Rate of patients with a 2-point reduction on the Numeric Pain Rating Scale (NPRS) of osteoarticular and/or musculoskeletal pain due to hormonal therapy treatment between T0 (inclusion) and T2 (end of treatment).
Secondary outcomes
the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy
The evolution of osteoarticular and/or musculoskeletal pain characteristics will be described according to the questionnaire "BPI- Brief Pain Inventory"
the patient compliance at yoga-therapeutic education session and yoga self-practice
The patient attendance at yoga-therapeutic education session and yoga self-practice will be noted on the logbooks filled out by the patients.
the reasons for adhesion or non-adhesion to yoga self-practice
The reasons why patients practice or do not practice yoga at home will be noted on the logbooks filled out by the patient
To assess forward-flexion flexibility
Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.
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