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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • educational yoga program

    Behavioral

    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)

  • no intervention

    Other intervention

    no yoga session at home and no yoga -therapeutic educatuion session

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 1 intervention
Group B: control armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 weeks

Secondary outcomes

1

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"

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

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