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

Breast Cancer Clinical Trial

— SKYPE2  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457895
• Other study ID #: PROICM 2020-05 SKY
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Moussion Aurore
• Phone: +33467612446
• Email: aurore.moussion[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• educational yoga program
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)

Other:
• no intervention
no yoga session at home and no yoga -therapeutic educatuion session

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Angers	Pays De La Loire
France	CH Libourne	Libourne	Aquitaine
France	Icm Val D'Aurelle	Montpellier	Herault
France	CHU Nîmes	Nîmes	Herault
France	Institut du sein Basque	Tosse	Nouvelle Aquitaine
France	Insitut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy	Meurthe-et-Moselle,

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (18)

Bower JE, Greendale G, Crosswell AD, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Arevalo J, Cole SW. Yoga reduces inflammatory signaling in fatigued breast cancer survivors: a randomized controlled trial. Psychoneuroendocrinology. 2014 May;43:20-9. doi: 10.1016/j.psyneuen.2014.01.019. Epub 2014 Jan 30. — View Citation

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Chandwani 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. — View Citation

Cramer 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. — View Citation

Crew 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. — View Citation

Djalilova 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. — View Citation

Felson 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. — View Citation

Galantino 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. — View Citation

Greenlee 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. Erratum In: J Natl Cancer Inst Monogr. 2015 May;2015(51):98. — View Citation

Kiecolt-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. — View Citation

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. — View Citation

Lombard 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. — View Citation

Long Parma D, Hughes DC, Ghosh S, Li R, Trevino-Whitaker RA, Ogden SM, Ramirez AG. Effects of six months of Yoga on inflammatory serum markers prognostic of recurrence risk in breast cancer survivors. Springerplus. 2015 Mar 26;4:143. doi: 10.1186/s40064-015-0912-z. eCollection 2015. — View Citation

Lyman 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. — View Citation

Olsson 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. — View Citation

Peppone 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. — View Citation

Rao RM, Vadiraja HS, Nagaratna R, Gopinath KS, Patil S, Diwakar RB, Shahsidhara HP, Ajaikumar BS, Nagendra HR. Effect of Yoga on Sleep Quality and Neuroendocrine Immune Response in Metastatic Breast Cancer Patients. Indian J Palliat Care. 2017 Jul-Sep;23(3):253-260. doi: 10.4103/IJPC.IJPC_102_17. — View Citation

Sharma 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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"	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	To assess respiratory capacity	Respiratory capacity will be measured with a spirometer (Forced Expiratory Volume in 1 second (FEV1)	12 weeks
Secondary	the hormone therapy treatment and its compliance	Taking hormonotherapy treatments will be reported in a log-book by the patients	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	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	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	the patients' satisfaction towards the program	Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy	12 weeks
Secondary	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	12 weeks