Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
SKYPE2
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.
1 other identifier
interventional
108
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Feb 2021
Longer than P75 for not_applicable breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
February 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
February 5, 2026
November 1, 2025
7.5 years
June 23, 2020
February 3, 2026
Conditions
Keywords
Outcome Measures
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).
12 weeks
Secondary Outcomes (14)
the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy
12 weeks
the patient compliance at yoga-therapeutic education session and yoga self-practice
12 weeks
the reasons for adhesion or non-adhesion to yoga self-practice
12 weeks
To assess forward-flexion flexibility
12 weeks
To assess respiratory capacity
12 weeks
- +9 more secondary outcomes
Study Arms (2)
Experimental arm
EXPERIMENTALFor 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.
control arm
PLACEBO COMPARATORThe 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Non metastatic breast cancer
- Osteoarticular and/or musculoskeletal pain due to HT ≥ 4 on the Numeric Pain Rating Scale (NPRS)
- Informed patient and signed informed consent received
- Affiliation to a social security system
You may not qualify if:
- Chronic rhumatologic pain with specific care needed
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CH Libourne
Libourne, Aquitaine, 33500, France
Icm Val D'Aurelle
Montpellier, Herault, 34298, France
CHU Nîmes
Nîmes, Herault, 30029, France
Insitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, 54519, France
Institut Bergonié
Bordeaux, Nouvelle-Aquitaine, 33076, France
Institut du sein Basque
Tosse, Nouvelle-Aquitaine, 40230, France
Institut de Cancérologie de l'Ouest
Angers, Pays de la Loire Region, 49055, France
Related Publications (20)
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PMID: 17761973BACKGROUNDLyman GH, Greenlee H, Bohlke K, Bao T, DeMichele AM, Deng GE, Fouladbakhsh JM, Gil B, Hershman DL, Mansfield S, Mussallem DM, Mustian KM, Price E, Rafte S, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline. J Clin Oncol. 2018 Sep 1;36(25):2647-2655. doi: 10.1200/JCO.2018.79.2721. Epub 2018 Jun 11.
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PMID: 28045199BACKGROUNDKiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
PMID: 24470004BACKGROUNDChandwani KD, Perkins G, Nagendra HR, Raghuram NV, Spelman A, Nagarathna R, Johnson K, Fortier A, Arun B, Wei Q, Kirschbaum C, Haddad R, Morris GS, Scheetz J, Chaoul A, Cohen L. Randomized, controlled trial of yoga in women with breast cancer undergoing radiotherapy. J Clin Oncol. 2014 Apr 1;32(10):1058-65. doi: 10.1200/JCO.2012.48.2752. Epub 2014 Mar 3.
PMID: 24590636BACKGROUNDGreenlee H, Balneaves LG, Carlson LE, Cohen M, Deng G, Hershman D, Mumber M, Perlmutter J, Seely D, Sen A, Zick SM, Tripathy D; Society for Integrative Oncology. Clinical practice guidelines on the use of integrative therapies as supportive care in patients treated for breast cancer. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):346-58. doi: 10.1093/jncimonographs/lgu041.
PMID: 25749602BACKGROUNDOlsson Moller U, Beck I, Ryden L, Malmstrom M. A comprehensive approach to rehabilitation interventions following breast cancer treatment - a systematic review of systematic reviews. BMC Cancer. 2019 May 20;19(1):472. doi: 10.1186/s12885-019-5648-7.
PMID: 31109309BACKGROUNDFelson DT, Cummings SR. Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Arthritis Rheum. 2005 Sep;52(9):2594-8. doi: 10.1002/art.21364. No abstract available.
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PMID: 28827927BACKGROUNDFaravel K, Jarlier M, Meignant L, Thomaso M, Del Rio M, Jacot W, Stoebner A. Efficacy of a physiotherapy, yoga and patient education programme for patients with breast cancer and hormone therapy-induced pain: a multicentre randomised study protocol (SKYPE 2). BMJ Open. 2024 Jan 8;14(1):e075378. doi: 10.1136/bmjopen-2023-075378.
PMID: 38191246BACKGROUNDMesser S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.
PMID: 40421669DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kerstin Faravel
ICM Val d'Aurelle
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
July 7, 2020
Study Start
February 11, 2021
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
February 5, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients All participant data collected during the trial, after coding by an inclusion number, 1st letter of the surname and first name can be shared. Participant data will be available upon request and with the completion of a contract between the sponsor and the applicant. The study protocol, the statistical analysis plan and the analytical code may also be subject to data sharing under a transfer contract (EU-MCR).