- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04408560
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
Status
Completed
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Pain
- Neurologic Manifestations
- Breast Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Breast Neoplasms
- Arthralgia
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Acetaminophen
- Analgesics
Other Study ID Numbers
- 2018-A01019-46
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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