Yoga and education program for breast cancer patients experiencing pain from hormone therapy
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.
This study is testing a yoga and education program to see if it can help breast cancer patients manage pain from hormone therapy and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Libourne, Aquitaine and 6 other locations) |
| Trial ID | NCT04457895 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a physical therapy and yoga-based educational program designed for breast cancer patients suffering from osteoarticular pain due to hormone therapy. The program aims to empower patients by teaching them yoga postures that they can practice at home, enhancing their self-efficacy and quality of life. The approach combines therapeutic education with physical activity to address pain management and improve overall well-being. The study is conducted at multiple locations in France, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include adult women with non-metastatic breast cancer who are currently undergoing hormone therapy and experiencing moderate to severe pain.
Not a fit: Patients with chronic rheumatologic pain requiring specific care or those who have practiced yoga regularly in the past three months may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce pain and improve the quality of life for breast cancer patients undergoing hormone therapy.
How similar studies have performed: Previous studies have shown positive outcomes with yoga interventions for pain management in breast cancer patients, indicating potential for success in this innovative approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Libourne, Aquitaine and 6 other locations
- CH Libourne — Libourne, Aquitaine, France (Recruiting)
- Icm Val D'Aurelle — Montpellier, Herault, France (Recruiting)
- CHU Nîmes — Nîmes, Herault, France (Recruiting)
- Insitut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France (Recruiting)
- Institut Bergonié — Bordeaux, New Aquitaine, France (Recruiting)
- Institut du sein Basque — Tosse, New Aquitaine, France (Recruiting)
- Institut de Cancérologie de l'Ouest — Angers, Pays de la Loire Region, France (Recruiting)
Study contacts
- Study coordinator: Moussion Aurore
- Email: aurore.moussion@icm.unicancer.fr
- Phone: +33467612446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.