Breast CancerSKYPE2NCT04457895
Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
A study testing educational yoga program in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- educational yoga program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 7 sitesFrance
- Study dates
- 11 Feb 2021to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, Pays de la Loire Region, 49055
anne Patsouris, MD, anne.patsouris@ico.unicancer.fr
- Recruiting
Institut Bergonié
Bordeaux, New Aquitaine, 33076
Hélène Hélène CHARITANSKY, MD, 0556333237 ext. +33, h.charitansky@bordeaux.unicancer.fr
- Recruiting
CH Libourne
Libourne, Aquitaine, 33500
Muriel GARCIA-RAMIREZ, MD, muriel.gracia-ramirez@ch-libourne.fr
- Recruiting
Icm Val D'Aurelle
Montpellier, Herault, 34298
kerstin Faravel, kerstin.faravel@icm.unicancer.fr
- Recruiting
CHU Nîmes
Nîmes, Herault, 30029
Alice CUENANT, MD, alice.cuenant@chu-nimes.fr
- Recruiting
Institut du sein Basque
Tosse, New Aquitaine, 40230
Angélique Ducteil, MD, angelique.ducteil@copb.eu
- Recruiting
Insitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, 54519
Cécile Delattre, MD, c.delattre@nancy.unicancer.fr
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- educational yoga program, no intervention
- Keywords
- breast cancer, hormonotherapy, osteo articular pain, yoga, patient educational project
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational yoga programBehavioural
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 interventionOther
no yoga session at home and no yoga -therapeutic educatuion session
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | For 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. Receives: Behavioral: educational yoga program |
| control arm | Placebo comparator | The 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (14)
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"
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
To assess respiratory capacity
Respiratory capacity will be measured with a spirometer (Forced Expiratory Volume in 1 second (FEV1)
Measured: 12 weeks
the hormone therapy treatment and its compliance
Taking hormonotherapy treatments will be reported in a log-book by the patients
Measured: 12 weeks
to assess quality of life by short form questionnaire
Quality of life will be measured by EORTC SF-36 questionnaire (European Organisation for Research and Treatment of Cancer, Short Form)
Measured: 12 weeks
to assess quality of life by Quality of Life Questionnaire
Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire)
Measured: 12 weeks
to assess quality of life by Quality of Life Questionnaire specify for Breast Cance
Quality of life will be measured by EORTC QLQ-BR23 questionnaires (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire specify for Breast Cancer)
Measured: 12 weeks
to assess fatigue
Fatigue will be measured by the Fatigue dimension of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire
Measured: 12 weeks
anxiety and depression
Anxiety and depression will be measured by HADS scale (Hospital Anxiety and Depression Scale) (if score or = 9, result is no significant, if sore is between 10 and 12, result is limit, if result is > or = 13, result is significant)
Measured: 12 weeks
the induced self-competence feeling
The self-competence feeling induced will be assessed using the GSES (General Self Efficacy-Schwarzer) questionnaire (10 questions - scale 1- not at all true to 4-totally true)
Measured: 12 weeks
the patients' satisfaction towards the program
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy
Measured: 12 weeks
the patient's inflammatory biological profile
The inflammatory biological profile of the patient will be determined by correlation of cytokine levels at the beginning (T0) and end (T2) of the protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start11 Feb 2021
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin Faravel, Study chair, ICM Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457895
- Sponsor's protocol ID
- PROICM 2020-05 SKY
- Acronym
- SKYPE2
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Publications
Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11.
PubMed 24816806Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS(c)(R) yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27.
PubMed 25814054Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83. doi: 10.1200/JCO.2007.10.7573.
PubMed 17761973Lyman 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.
PubMed 29889605Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10.
PubMed 26556210Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6.
PubMed 21733988Sharma M, Lingam VC, Nahar VK. A systematic review of yoga interventions as integrative treatment in breast cancer. J Cancer Res Clin Oncol. 2016 Dec;142(12):2523-2540. doi: 10.1007/s00432-016-2269-2. Epub 2016 Sep 15.
PubMed 27630024Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1(1):CD010802. doi: 10.1002/14651858.CD010802.pub2.
PubMed 28045199Kiecolt-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.
PubMed 24470004Chandwani 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.
PubMed 24590636Greenlee 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.
PubMed 25749602Olsson 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.
PubMed 31109309Felson 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.
PubMed 16142740Bower JE, Irwin MR. Mind-body therapies and control of inflammatory biology: A descriptive review. Brain Behav Immun. 2016 Jan;51:1-11. doi: 10.1016/j.bbi.2015.06.012. Epub 2015 Jun 23.
PubMed 26116436Djalilova DM, Schulz PS, Berger AM, Case AJ, Kupzyk KA, Ross AC. Impact of Yoga on Inflammatory Biomarkers: A Systematic Review. Biol Res Nurs. 2019 Mar;21(2):198-209. doi: 10.1177/1099800418820162. Epub 2018 Dec 20.
PubMed 30572710
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04457895
- Acronym / sponsor ID
- SKYPE2 / PROICM 2020-05 SKY
- Conditions
- Breast Cancer
- Keywords
- breast cancer, hormonotherapy, osteo articular pain, yoga, patient educational project
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: educational yoga programFor 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 comparator | Other: no interventionThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational yoga programDaily 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) | Behavioural | Experimental arm |
| no interventionno yoga session at home and no yoga -therapeutic educatuion session | Other | control arm |
Primary outcome
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.
Time frame: 12 weeks
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).
14 secondary outcomes
the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy
Time frame: 12 weeks
the patient compliance at yoga-therapeutic education session and yoga self-practice
Time frame: 12 weeks
the reasons for adhesion or non-adhesion to yoga self-practice
Time frame: 12 weeks
To assess forward-flexion flexibility
Time frame: 12 weeks
To assess respiratory capacity
Time frame: 12 weeks
the hormone therapy treatment and its compliance
Time frame: 12 weeks
to assess quality of life by short form questionnaire
Time frame: 12 weeks
to assess quality of life by Quality of Life Questionnaire
Time frame: 12 weeks
to assess quality of life by Quality of Life Questionnaire specify for Breast Cance
Time frame: 12 weeks
to assess fatigue
Time frame: 12 weeks
anxiety and depression
Time frame: 12 weeks
the induced self-competence feeling
Time frame: 12 weeks
the patients' satisfaction towards the program
Time frame: 12 weeks
the patient's inflammatory biological profile
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 24816806Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11.
- Background: PubMed 25814054Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS(c)(R) yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27.
- Background: PubMed 17761973Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83. doi: 10.1200/JCO.2007.10.7573.
- Background: PubMed 29889605Lyman 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.
- Background: PubMed 26556210Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10.
- Background: PubMed 21733988Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6.
- Background: PubMed 27630024Sharma M, Lingam VC, Nahar VK. A systematic review of yoga interventions as integrative treatment in breast cancer. J Cancer Res Clin Oncol. 2016 Dec;142(12):2523-2540. doi: 10.1007/s00432-016-2269-2. Epub 2016 Sep 15.
- Background: PubMed 28045199Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1(1):CD010802. doi: 10.1002/14651858.CD010802.pub2.
- Background: PubMed 24470004Kiecolt-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.
- Background: PubMed 24590636Chandwani 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.
- Background: PubMed 25749602Greenlee 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.
- Background: PubMed 31109309Olsson 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.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerstin Faravel study chair
ICM Val d'Aurelle
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational yoga program in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moussion Aurore (+33467612446 ext. +33, aurore.moussion@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04457895, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.