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

Overview

Interventional, randomised, prospective, monocentric study

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 27, 2021

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

  • Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)
    • Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
  • Other: paracetamol (drug analgesic class1)
    • paracetamol (drug analgesic class1)

Arms, Groups and Cohorts

  • Active Comparator: Groupe A with homéopathic treatment
    • Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH
  • Sham Comparator: Groupe B without homeopathic treatment
    • Conventional treatment : paracetamol (drug analgesic class1)

Clinical Trial Outcome Measures

Primary Measures

  • Evolution of the score of “most intense pain” during the first 3 months of treatment with AI
    • Time Frame: 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 Measures

  • Evolution of joint pain
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 3 months
    • Percentage of patients for whom pain and / or stiffness have occurred.
  • Time of onset or aggravation of pain
    • Time Frame: 6 months
    • time from which the “most severe pain” score has increased for at least 2 consecutive weeks since the Visit 1 score

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Jean-Godinot
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • PHILIPPE GUILBERT, Principal Investigator, Institut Jean-Godinot

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