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

Breast Cancer Female Clinical Trial

— ARHOMA2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408560
• Other study ID #: 2018-A01019-46
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: March 23, 2022

Study information

• Verified date: September 2022
• Source: Institut Jean-Godinot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional, randomised, prospective, monocentric study

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 23, 2022
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer Female
• Breast Neoplasms
• Joint Pain

Intervention

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)

Locations

Country	Name	City	State
France	Philippe GUILBERT	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Institut Jean-Godinot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months
Secondary	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	6 months
Secondary	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)	3 months
Secondary	Rate of onset of pain and joint stiffness	Percentage of patients for whom pain and / or stiffness have occurred.	3 months
Secondary	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	6 months