Breast Cancer Female, Joint Pain
Conditions
Brief summary
Interventional, randomised, prospective, monocentric study
Detailed 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: 01/09/2021 * End date of follow-up: 23/03/2022 * Study report: 23/03/2023
Interventions
DRUGRhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)
Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
OTHERparacetamol (drug analgesic class1)
paracetamol (drug analgesic class1)
Sponsors
Institut Jean-Godinot
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the score of most intense pain during the first 3 months of treatment with AI | 3 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of joint pain | 6 months | 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 |
| Rate of onset of joint pain and stiffness | 3 months | 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) |
| Rate of onset of pain and joint stiffness | 3 months | Percentage of patients for whom pain and / or stiffness have occurred. |
| Time of onset or aggravation of pain | 6 months | time from which the most severe pain score has increased for at least 2 consecutive weeks since the Visit 1 score |
Countries
France
Outcome results
None listed