Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment. (SKYPE2)

June 2, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Aquitaine
    • Herault
    • Meurthe-et-Moselle,
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France, 54519
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
      • Tosse, New Aquitaine, France, 40230
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm

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.
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)
Placebo Comparator: control arm
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.
Other: no intervention
no yoga session at home and no yoga -therapeutic educatuion session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy
Time Frame: 12 weeks
The evolution of osteoarticular and/or musculoskeletal pain characteristics will be described according to the questionnaire "BPI- Brief Pain Inventory"
12 weeks
the patient compliance at yoga-therapeutic education session and yoga self-practice
Time Frame: 12 weeks
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
the reasons for adhesion or non-adhesion to yoga self-practice
Time Frame: 12 weeks
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
To assess forward-flexion flexibility
Time Frame: 12 weeks
Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.
12 weeks
To assess respiratory capacity
Time Frame: 12 weeks
Respiratory capacity will be measured with a spirometer (Forced Expiratory Volume in 1 second (FEV1)
12 weeks
the hormone therapy treatment and its compliance
Time Frame: 12 weeks
Taking hormonotherapy treatments will be reported in a log-book by the patients
12 weeks
to assess fatigue
Time Frame: 12 weeks
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
anxiety and depression
Time Frame: 12 weeks
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
the induced self-competence feeling
Time Frame: 12 weeks
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
the patients' satisfaction towards the program
Time Frame: 12 weeks
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy
12 weeks
the patient's inflammatory biological profile
Time Frame: 12 weeks
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
to assess quality of life by short form questionnaire
Time Frame: 12 weeks
Quality of life will be measured by EORTC SF-36 questionnaire (European Organisation for Research and Treatment of Cancer, Short Form)
12 weeks
to assess quality of life by Quality of Life Questionnaire
Time Frame: 12 weeks
Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire)
12 weeks
to assess quality of life by Quality of Life Questionnaire specify for Breast Cance
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Kerstin Faravel, ICM Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2020-05 SKY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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