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

Primary Purpose

Musculoskeletal Pain, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auriculotherapy for analgesic use
Placebo auriculotherapy
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Musculoskeletal Pain focused on measuring auriculotherapy, aromatase inhibitors, adjuvant treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre François BaclesseRecruiting
  • Hôpital Privé Paul d'EgineRecruiting
  • Hôpital Cognac-Jay - ForcillesRecruiting
  • CHU GrenobleRecruiting
  • Centre Oscar LambretRecruiting
  • Groupe Hospitalier Paris St JosephRecruiting
  • IGRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental arm

Controle arm

Arm Description

Auriculotherapy for analgesic use

Placebo auriculotherapy

Outcomes

Primary Outcome Measures

Decrease in the overall pain score
The proportion of patients with a 2-point or greater decrease in the overall pain

Secondary Outcome Measures

Full Information

First Posted
March 20, 2017
Last Updated
May 12, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT03096041
Brief Title
Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Breast Cancer
Keywords
auriculotherapy, aromatase inhibitors, adjuvant treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blind
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Auriculotherapy for analgesic use
Arm Title
Controle arm
Arm Type
Placebo Comparator
Arm Description
Placebo auriculotherapy
Intervention Type
Device
Intervention Name(s)
Auriculotherapy for analgesic use
Intervention Description
The ASP will be applied to specific pain points
Intervention Type
Device
Intervention Name(s)
Placebo auriculotherapy
Intervention Description
The ASP will be applied to placebo points (not specific to pain)
Primary Outcome Measure Information:
Title
Decrease in the overall pain score
Description
The proportion of patients with a 2-point or greater decrease in the overall pain
Time Frame
3 months after auriculotherapy initiation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie LELOUP-MORIT, MD
Phone
0231455050
Email
v.leloupmorit@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Virginie LELOUP-MORIT
Facility Name
Hôpital Privé Paul d'Egine
City
Champigny sur Marne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freddy KAYEMBE, MD
Phone
01 49 83 67 21
Facility Name
Hôpital Cognac-Jay - Forcilles
City
Férolles-Attilly
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David GUIGOU, MD
Email
dguigou@cognacq-jay.fr
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina COSTAN, MD
Phone
0476765213
Email
ccostan@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Cristina COSTAN
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora ALLOY, MD
Email
n-alloy@o-lambret.fr
Facility Name
Groupe Hospitalier Paris St Joseph
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel STAUDACHER, MD
Phone
0144127147
Email
lstaudacher@hpsj.fr
First Name & Middle Initial & Last Name & Degree
Lionel STAUDACHER, MD
Facility Name
IGR
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine PAILLER, MD
Email
christine.pailler@gustaveroussy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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