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.

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Institut de Cancérologie de l'Ouest
RECRUITING
Angers
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
CH Libourne
RECRUITING
Libourne
Icm Val D'Aurelle
RECRUITING
Montpellier
CHU Nîmes
RECRUITING
Nîmes
Institut du sein Basque
RECRUITING
Tosse
Insitut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Moussion Aurore
aurore.moussion@icm.unicancer.fr
+33467612446
Backup
Emmanuelle Texier
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Time Frame
Start Date: 2021-02-11
Estimated Completion Date: 2028-08
Participants
Target number of participants: 108
Treatments
Experimental: Experimental arm
For experimental arm patients, there will be a 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga (the first on site and by videoconference for the others).~Starting the first day of the yoga practice there will be one daily 15 min session at home with My Yoga Guide and the audio guide during 12 weeks.
Placebo_comparator: control arm
The control arm patients will have standard care. They will be proposed to participate in the physical therapy - yoga - educational program after the end of the study.
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov