Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer (ARHOMA2)

September 16, 2022 updated by: Institut Jean-Godinot

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

Interventional, randomised, prospective, monocentric study

Study Overview

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reims, France, 51100
        • Philippe GUILBERT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
paracetamol (drug analgesic class1)
Sham Comparator: Groupe B without homeopathic treatment
Conventional treatment : paracetamol (drug analgesic class1)
paracetamol (drug analgesic class1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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)
3 months
Rate of onset of pain and joint stiffness
Time Frame: 3 months
Percentage of patients for whom pain and / or stiffness have occurred.
3 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: PHILIPPE GUILBERT, Institut Jean-Godinot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2018

Primary Completion (Actual)

August 27, 2021

Study Completion (Actual)

March 23, 2022

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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