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)
1 other identifier
interventional
197
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedStudy Start
First participant enrolled
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2025
CompletedSeptember 12, 2025
September 1, 2025
8 years
March 20, 2017
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Experimental arm
EXPERIMENTALAuriculotherapy for analgesic use
Controle arm
PLACEBO COMPARATORPlacebo auriculotherapy
Interventions
The ASP will be applied to specific pain points
The ASP will be applied to placebo points (not specific to pain)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Centre François Baclesse
Caen, 14000, France
Hôpital Privé Paul d'Egine
Champigny-sur-Marne, France
Hôpital Cognac-Jay - Forcilles
Férolles-Attilly, France
CHU Grenoble
Grenoble, France
Centre Oscar Lambret
Lille, France
Groupe Hospitalier Paris St Joseph
Paris, France
IGR
Villejuif, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single blind
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2017
First Posted
March 30, 2017
Study Start
July 5, 2017
Primary Completion
July 7, 2025
Study Completion
July 7, 2025
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share