Informations générales (source: ClinicalTrials.gov)
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) (TRIPLE-A)
Interventional
N/A
Centre Francois Baclesse (Voir sur ClinicalTrials)
juillet 2017
décembre 2025
06 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christine PAILLER | 20/03/2024 12:36:23 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOP FORCILLES FONDATION COGNACQ JAY | David GUIGOU, MD | Contact (sur clinicalTrials) | |||
| HOPITAL PRIVE PAUL D EGINE | Freddy KAYEMBE, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14000 - Caen - France | Virginie LELOUP-MORIT, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Grenoble - Grenoble - France | Cristina COSTAN, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Paris St Joseph - Paris - France | Lionel STAUDACHER, MD | Contact (sur clinicalTrials) | |||
| IGR - Villejuif - France | Christine PAILLER, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
- 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
- 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