Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer
Keywords
Abstract
Description
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: 01/09/2020 (duration to possibly adapt in order to obtain the number of required patients)
- End date of follow-up: 01/03/2021
- Study report: 01/09/2021
Dates
| Last Verified: | 09/30/2019 |
| First Submitted: | 04/03/2019 |
| Estimated Enrollment Submitted: | 05/25/2020 |
| First Posted: | 05/28/2020 |
| Last Update Submitted: | 05/25/2020 |
| Last Update Posted: | 05/28/2020 |
| Actual Study Start Date: | 09/05/2018 |
| Estimated Primary Completion Date: | 08/31/2020 |
| Estimated Study Completion Date: | 08/31/2021 |
Condition or disease
Intervention/treatment
Drug: Groupe A with homéopathic treatment
Other: paracetamol (drug analgesic class1)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Groupe A with homéopathic treatment Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH | Drug: Groupe A with homéopathic treatment Rhus toxicodendron 9 CH + Ruta graveolens 5 CH |
| Sham Comparator: Groupe B without homeopathic treatment Conventional treatment : paracetamol (drug analgesic class1) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Evolution of the score of "most intense pain" during the first 3 months of treatment with AI [3 months]
Secondary Outcome Measures
1. Evolution of joint pain [6 months]
2. Rate of onset of joint pain and stiffness [3 months]
3. Rate of onset of pain and joint stiffness [3 months]
4. Time of onset or aggravation of pain [6 months]
