Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
FEMALE
NCT04457895

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

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-02-05

108

Participants Needed

7

Research Sites

389 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with non-metastatic breast cancer
  • Currently receiving hormone therapy with no changes in treatment during the 30 days before joining
  • Experiencing osteoarticular and/or musculoskeletal pain rated 4 or higher on the Numeric Pain Rating Scale
  • Completed previous treatments (surgery, chemotherapy, or radiotherapy) at least 2 months before joining
  • Provided informed consent
  • Affiliated with a social security system
Not Eligible

You will not qualify if you...

  • Having chronic rheumatologic pain requiring specific care
  • Practicing yoga regularly in the 3 months before joining
  • Having medical reasons or conditions preventing physical activity
  • Being unable to attend regular follow-up due to psychological, family, social, or geographic reasons
  • Being pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 7 locations

1

CH Libourne

Libourne, Aquitaine, France, 33500

Actively Recruiting

2

Icm Val D'Aurelle

Montpellier, Herault, France, 34298

Actively Recruiting

3

CHU Nîmes

Nîmes, Herault, France, 30029

Actively Recruiting

4

Insitut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France, 54519

Actively Recruiting

5

Institut Bergonié

Bordeaux, New Aquitaine, France, 33076

Actively Recruiting

6

Institut du sein Basque

Tosse, New Aquitaine, France, 40230

Actively Recruiting

7

Institut de Cancérologie de l'Ouest

Angers, Pays de la Loire Region, France, 49055

Actively Recruiting

Loading map...

Research Team

M

Moussion Aurore

CONTACT

E

Emmanuelle Texier

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here