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

Institut Jean-Godinot140 enrolled

Overview

Interventional, randomised, prospective, monocentric study

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Breast Cancer Female Joint Pain

Interventions

Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)DRUG

Rhus toxicodendron 9 CH + Ruta graveolens 5 CH

paracetamol (drug analgesic class1)OTHER

paracetamol (drug analgesic class1)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Philippe GUILBERT

Reims, France

Outcomes

Primary Outcomes

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)

Time frame: 3 months

Secondary Outcomes

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

Time frame: 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)

Time frame: 3 months

Rate of onset of pain and joint stiffness

Percentage of patients for whom pain and / or stiffness have occurred.

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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