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

Not Applicable

Completed

• Conditions: Breast Cancer Female; Joint Pain
• Interventions: Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules); Other: paracetamol (drug analgesic class1)

• Registration Number: NCT04408560
• Lead Sponsor: Institut Jean-Godinot

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

Study Timeline

• Study Start: 2018-09-13
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-29
• Primary Completion: 2021-08-27
• Study Completion: 2022-03-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Groupe A with homéopathic treatment	paracetamol (drug analgesic class1)	Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH
Groupe A with homéopathic treatment	Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)	Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH
Groupe B without homeopathic treatment	paracetamol (drug analgesic class1)	Conventional treatment : paracetamol (drug analgesic class1)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Philippe GUILBERT; 🇫🇷 Reims, France