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

Breast Cancer Clinical Trial

— TRIPLE-A  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096041
• Other study ID #: TRIPLE-A
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Musculoskeletal Pain

Intervention

Device:
• Auriculotherapy for analgesic use
The ASP will be applied to specific pain points
• Placebo auriculotherapy
The ASP will be applied to placebo points (not specific to pain)

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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