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

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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Musculoskeletal Pain
• Intervention / Treatment: Device: Auriculotherapy for analgesic use; Device: Placebo auriculotherapy

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Centre Francois Baclesse
  • Champigny-sur-Marne, France
    • Hôpital Privé Paul d'Egine
  • Férolles-Attilly, France
    • Hôpital Cognac-Jay - Forcilles
  • Grenoble, France
    • CHU Grenoble
  • Lille, France
    • Centre Oscar Lambret
  • Paris, France
    • Groupe Hospitalier Paris St Joseph
  • Villejuif, France
    • IGR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 7, 2025

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: aromatase inhibitors; adjuvant treatment; auriculotherapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Musculoskeletal Pain; Breast Neoplasms; Therapeutics; Complementary Therapies; Auriculotherapy
• Other Study ID Numbers: TRIPLE-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No