Clinical trial NCT03096041: Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Breast Cancer
Keywords: auriculotherapy
aromatase inhibitors
adjuvant treatment
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Decrease in the overall pain score
timeFrame: 3 months after auriculotherapy initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Champigny sur Marne
country: France
facility: Hôpital Privé Paul d'Egine
city: Férolles-Attilly
country: France
facility: Hôpital Cognac-Jay - Forcilles
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Centre Oscar Lambret
city: Paris
country: France
facility: Groupe Hospitalier Paris St Joseph
city: Villejuif
country: France
facility: IGR
Study officials:
References: