NCT04457895 Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
| NCT ID | NCT04457895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2021-02-11 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2021-02-11 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kerstin Faravel
STUDY CHAIR
ICM Val d'Aurelle
Frequently Asked Questions
Who can join the NCT04457895 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04457895 currently recruiting?
Yes, NCT04457895 is actively recruiting participants. Contact the research team at aurore.moussion@icm.unicancer.fr for enrollment information.
Where is the NCT04457895 trial being conducted?
This trial is being conducted at Libourne, France, Montpellier, France, Nîmes, France, Vandœuvre-lès-Nancy, France and 3 additional locations.
Who is sponsoring the NCT04457895 clinical trial?
NCT04457895 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Kerstin Faravel at ICM Val d'Aurelle. The trial plans to enroll 108 participants.
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