Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors

Study Overview
=================
Brief Summary
-----------------
Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.

Official Title
-----------------
Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)

Conditions
-----------------
Musculoskeletal Pain, Breast Cancer

Intervention / Treatment
-----------------
* Device: Auriculotherapy for analgesic use
* Device: Placebo auriculotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years of age Patients with anti-aromatases in adjuvant treatment of breast cancer Menopausal women Treatment with aromatase inhibitors (anti-aromatase, AA) initiated for more than 3 months. In the case of a change in anti-aromatase, the last treatment must be started for more than 3 months. Musculoskeletal pain appearing or increased under AA: Overall pain score of QCD ≥3 (on a scale of 0 to 10) Pain on at least 2 sites Pain for at least 3 months History of radiotherapy and / or adjuvant chemotherapy authorized Patients may have received tamoxifen Patient affiliated to a social security system Patient mastering the French language and able to complete the evaluation questionnaires Free and Informed Consent Exclusion Criteria: Patients who have already undergone treatment in auriculotherapy for the same indication Patient benefiting at the same time from a PNCAVT (acupuncture or homeopathy) for musculoskeletal pain Wearing hearing aids hindering the placement of semi-permanent needles (ASP) Wearing of a valve prosthesis Patient under guardianship or unable to give informed consent Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Auriculotherapy for analgesic use | Device: Auriculotherapy for analgesic use<br>* The ASP will be applied to specific pain points<br>|
| Placebo Comparator: Controle arm<br>Placebo auriculotherapy | Device: Placebo auriculotherapy<br>* The ASP will be applied to placebo points (not specific to pain)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the overall pain score | The proportion of patients with a 2-point or greater decrease in the overall pain | 3 months after auriculotherapy initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
auriculotherapy, aromatase inhibitors, adjuvant treatment