NCT04001751

Brief Summary

As much as 45 to 60% 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. With this project, the investigators will assess the feasibility of a therapeutic yoga program with home practice for patients with breast cancer treated with hormonotherapy. The investigators will measure adhesion of the patients to perform yoga postures in an autonomous manner. Our study will also allow collection of data on the effect of such a program on quality of life, in view of setting-up an intervention study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 31, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

February 5, 2026

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

June 7, 2019

Last Update Submit

February 3, 2026

Conditions

Breast Cancer

Keywords

breast cancerhormonotherapyosteoarticular painyogatherapeutic patient education

Outcome Measures

Primary Outcomes (1)

  • proportion of patient compliance to the educational yoga program

    Compliance will be posittive if 70% of daily sessions at home and 4 sessions out of the 6 therapeutic educational (TEP) sessions delivered in the center by a physical therapist are realised

    12 weeks

Secondary Outcomes (12)

  • the patients' satisfaction towards the program

    12 weeks

  • the induced self-competency feeling

    12 weeks

  • To assess quality of life by Quality of Life Questionnaire

    12 weeks

  • To assess quality of life by Quality of Life Questionnaire specify for Breast Cancer

    12 weeks

  • To assess fatigue and stress

    12 weeks

  • +7 more secondary outcomes

Study Arms (1)

Therapeutic educational postural yoga program

EXPERIMENTAL

Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).

Behavioral: educational yoga program

Interventions

educational yoga programBEHAVIORAL

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 yoga.

Therapeutic educational postural yoga program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Non metastatic breast cancer
  • Osteoarticular pain ≥ 4 (resting or moving) on the VAS (Visual Analogue Scale)
  • Informed patient and signed informed consent received
  • Affiliation to a social security category

You may not qualify if:

  • Chronic rheumatologic pain with specific care needed
  • Contra-indication or clinical state not allowing physical practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (6)

  • 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.

    PMID: 24816806BACKGROUND

  • 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.

    PMID: 25814054BACKGROUND

  • 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.

    PMID: 17761973BACKGROUND

  • 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.

    PMID: 25749602BACKGROUND

  • 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.

    PMID: 26556210BACKGROUND

  • Faravel K, Huteau ME, Jarlier M, de Forges H, Meignant L, Senesse P, Norton J, Jacot W, Stoebner A. Importance of Patient Education for At-home Yoga Practice in Women With Hormonal Therapy-induced Pain During Adjuvant Breast Cancer Treatment: A Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211063791. doi: 10.1177/15347354211063791.

    PMID: 34939444RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kerstin FARAVEL

    Institut du Cancer de Montpellier - Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 28, 2019

Study Start

August 31, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

February 5, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)