Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
Recruiting · NCT04457895 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
- Previous treatment (surgery, chemotherapy or radiotherapy) ended at least 2 months before inclusion
- Informed patient and signed informed consent received
- Affiliation to a social security system
Exclusion criteria
- 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,
- Pregnant and breastfeeding woman
Where it is running
7 locations listed.
- 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