Clinical trial NCT04457895: Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
hormonotherapy
osteo articular pain
yoga
patient educational project
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Numerous initiatives have started in France, often associative. It is essential to evaluate in a rigorous manner, these therapies before making them part of the patient's care pathway.

Yoga has shown a real benefit in terms of pain reduction in patients with BC treated with HT. These osteoarticular pains are the secondary effect on which a physical therapeutic care can have a real benefit.

It thus appears innovative to complete this care with a therapeutic education program (TEP) in postural yoga which will enable patients to practice yoga postures at home by themselves. Yoga allows a large adaptation to pains expressed by each patient. It will favor the development of the feeling of control that they have in particular on their pain. participants will so improve the self-efficacy, the quality of life, and will reduce their fatigue and their pain. The patients involved have already lived major body transformations because of the disease and treatments. Yoga will help them put their lives together again, both physically and psychologically, and reclaim their body.

Studies have shown the short-term effects of yoga practice on anxiety, stress, pain and quality of life. Few rare studies have suggested that patients could add yoga practice at home to the supervised sessions, but these studies lacked therapeutic patient education. To date, to our knowledge, no data on the effect of the realization of yoga postures at home on increase of the patients' self-competency feeling are available in France. Also, the long-term effects of such programs need to be assessed.

The Montpellier Cancer Institute (ICM) has set-up 8 years ago yoga sessions for women with breast cancer, together with an association located in Montpellier.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy
timeFrame: 12 weeks
measure: the patient compliance at yoga-therapeutic education session and yoga self-practice
timeFrame: 12 weeks
measure: the reasons for adhesion or non-adhesion to yoga self-practice
timeFrame: 12 weeks
measure: To assess forward-flexion flexibility
timeFrame: 12 weeks
measure: To assess respiratory capacity
timeFrame: 12 weeks
measure: the hormone therapy treatment and its compliance
timeFrame: 12 weeks
measure: to assess quality of life by short form questionnaire
timeFrame: 12 weeks
measure: to assess quality of life by Quality of Life Questionnaire
timeFrame: 12 weeks
measure: to assess quality of life by Quality of Life Questionnaire specify for Breast Cance
timeFrame: 12 weeks
measure: to assess fatigue
timeFrame: 12 weeks
measure: anxiety and depression
timeFrame: 12 weeks
measure: the induced self-competence feeling
timeFrame: 12 weeks
measure: the patients' satisfaction towards the program
timeFrame: 12 weeks
measure: the patient's inflammatory biological profile
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Libourne
country: France
facility: CH Libourne
state: Aquitaine
city: Montpellier
country: France
facility: Icm Val D'Aurelle
state: Herault
city: Nîmes
country: France
facility: CHU Nîmes
state: Herault
city: Vandœuvre-lès-Nancy
country: France
facility: Insitut de Cancérologie de Lorraine
state: Meurthe-et-Moselle,
city: Tosse
country: France
facility: Institut du sein Basque
state: Nouvelle Aquitaine
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
state: Pays De La Loire
Study officials:
affiliation: ICM Val d'Aurelle
name: Kerstin Faravel
role: STUDY_CHAIR
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