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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03096041

Acronym

TRIPLE-A

Enrollment

197

Registered

2017-03-30

Start date

2017-07-05

Completion date

2025-07-07

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Musculoskeletal Pain

Keywords

auriculotherapy, aromatase inhibitors, adjuvant treatment

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.

Interventions

DEVICEAuriculotherapy for analgesic use

The ASP will be applied to specific pain points

DEVICEPlacebo auriculotherapy

The ASP will be applied to placebo points (not specific to pain)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Masking description

Single blind

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026