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

May 12, 2023 updated by: Centre Francois Baclesse

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • Centre François Baclesse
        • Contact:
        • Principal Investigator:
          • Virginie LELOUP-MORIT
      • Champigny sur Marne, France
        • Recruiting
        • Hopital Prive Paul d'Egine
        • Contact:
          • Freddy KAYEMBE, MD
          • Phone Number: 01 49 83 67 21
      • Férolles-Attilly, France
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
        • Principal Investigator:
          • Cristina COSTAN
      • Lille, France
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Paris St Joseph
        • Contact:
        • Principal Investigator:
          • Lionel STAUDACHER, MD
      • Villejuif, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months after auriculotherapy initiation
The proportion of patients with a 2-point or greater decrease in the overall pain
3 months after auriculotherapy initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 1, 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 (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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