Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer (ARHOMA2)

Evaluation of the Efficacy of a Homeopathic Protocol to Reduce the Onset or Aggravation of Joint Pain or Stiffness Following the Taking of Anti-aromatases (AI) in Patients With Non-metastatic Breast Cancer

Interventional, randomised, prospective, monocentric study Primary objective : Demonstrate the interest of the homeopathic Protocol to reduce the onset or aggravation of joint pain as a result of the taking of AI compared to conventional care Secondary objective : Compare between the two treatment groups: Evolution of joint pain Evolution of joint stiffness-rate of onset of pain and joint stiffness-delay in onset or aggravation of pain-evolution of the number of painful locations-evolution of the impact of pain on the quality of the sleep-consumption of permitted concomitant treatments (analgesics) Evolution of symptoms of hormonal deprivation-adherence to AI treatment Tolerance to AI Change seen by patients Stop rate and switch of AI-rate of recurrence of breast cancer Describe in patients receiving homeopathic treatment: Adherence to homeopathic treatment Tolerance to homeopathic treatment Group A: Group of patients receiving conventional treatment (drug analgesic class 1) for joint pain + homeopathic treatment Group B: Group of patients receiving conventional treatment (drug analgesic class 1) for joint pain Schedule : Inclusions start at: 01/09/2018 End date of inclusions: 01/09/2021 End date of follow-up: 23/03/2022 Study report: 23/03/2023

Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH

Evaluation comparing between the 2 groups the area under the most intense pain curve, measured each week during the first 3 months of AI treatment using the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort)

variation of different pain scores on the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) : pain severity score corresponding to the average of the 4 questions on pain intensity, and interference score corresponding to the average of the 7 questions on the impact of pain

For pain, among patients who answered "no" to the first question of Brief Pain Inventory-Short Form (1 no disconfort up to 10 complet disconfort) to visit 1, percentage of patients who answered "Yes" to 3 months (visit 2)

time from which the "most severe pain" score has increased for at least 2 consecutive weeks since the Visit 1 score

Inclusion Criteria: menopausal patient achieved histologically confirmed non-metastatic breast cancer with positive hormonal receptors starting an adjuvant anti-hormonal treatment with an AI patient benefiting from a social protection scheme patient mastering the French language -signature of free and informed consent - Exclusion Criteria: patient whose treatment with chemotherapy or radiotherapy is ongoing or anticipated during the theoretical period of the study or patient who has completed her chemotherapy treatment within a period of less than 4 weeks prior to the inclusion visit patient with proven inflammatory rheumatism already diagnosed with rheumatoid arthritis, lupus, psoriatic rheumatism, ankylosing spondylitis -concomitant treatment with other complementary medicines (excepted Vitamin D), unless the treatment has been stable for at least 1 month. current treatment with narcotic drugs or corticosteroids patient with overexpressing breast cancer HER2