Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors (TRIPLE-A)

Centre Francois Baclesse

Status

Completed

Conditions

Musculoskeletal Pain

Breast Cancer

Treatments

Device: Auriculotherapy for analgesic use

Device: Placebo auriculotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03096041

TRIPLE-A

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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