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

Study Overview
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Brief Summary
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Interventional, randomised, prospective, monocentric study

Detailed Description
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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

Official Title
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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

Conditions
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Breast Cancer Female, Joint Pain

Intervention / Treatment
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* Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)
* Other: paracetamol (drug analgesic class1)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Groupe A with homéopathic treatment<br>Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH | Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)<br>* Rhus toxicodendron 9 CH + Ruta graveolens 5 CH<br>Other: paracetamol (drug analgesic class1)<br>* paracetamol (drug analgesic class1)<br>|
| Sham Comparator: Groupe B without homeopathic treatment<br>Conventional treatment : paracetamol (drug analgesic class1) | Other: paracetamol (drug analgesic class1)<br>* paracetamol (drug analgesic class1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the score of most intense pain during the first 3 months of treatment with AI | 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of joint pain | 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 | 6 months | 
| Rate of onset of joint pain and stiffness | 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) | 3 months | 
| Rate of onset of pain and joint stiffness | Percentage of patients for whom pain and / or stiffness have occurred. | 3 months | 
| Time of onset or aggravation of pain | time from which the most severe pain score has increased for at least 2 consecutive weeks since the Visit 1 score | 6 months |