Evaluating auriculotherapy for musculoskeletal pain in breast cancer patients
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)
NA · Centre Francois Baclesse · NCT03096041
This study is testing if auriculotherapy can help menopausal women with breast cancer feel less musculoskeletal pain while they are on aromatase inhibitors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Francois Baclesse (other) |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Caen and 6 other locations) |
| Trial ID | NCT03096041 on ClinicalTrials.gov |
What this trial studies
This Phase 3 study investigates the efficacy of auriculotherapy as a complementary treatment for musculoskeletal pain in menopausal women undergoing adjuvant therapy with aromatase inhibitors for breast cancer. Participants will be randomly assigned to receive either active auriculotherapy or a placebo treatment. The study aims to validate the effectiveness of auriculotherapy in alleviating pain that may arise or worsen due to aromatase inhibitor treatment. The trial will assess pain levels using a standardized scoring system over a defined period.
Who should consider this trial
Good fit: Ideal candidates are menopausal women over 18 years old who have been on aromatase inhibitors for at least three months and are experiencing musculoskeletal pain.
Not a fit: Patients who have previously undergone auriculotherapy for the same condition or are currently receiving other complementary treatments for pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a low-cost, non-invasive pain management option for breast cancer patients experiencing musculoskeletal pain.
How similar studies have performed: While auriculotherapy has shown promise in treating intraoperative pain, its efficacy for musculoskeletal pain remains controversial, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen and 6 other locations
- Centre François Baclesse — Caen, France (RECRUITING)
- Hôpital Privé Paul d'Egine — Champigny sur Marne, France (RECRUITING)
- Hôpital Cognac-Jay - Forcilles — Férolles-Attilly, France (RECRUITING)
- CHU Grenoble — Grenoble, France (RECRUITING)
- Centre Oscar Lambret — Lille, France (RECRUITING)
- Groupe Hospitalier Paris St Joseph — Paris, France (RECRUITING)
- IGR — Villejuif, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Musculoskeletal Pain, Breast Cancer, auriculotherapy, aromatase inhibitors, adjuvant treatment