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

Institut Jean-Godinot

Status: Completed

Conditions: Breast Cancer Female; Joint Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04408560

2018-A01019-46

Details and patient eligibility

About

Interventional, randomised, prospective, monocentric study

Full 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

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Groupe A with homéopathic treatment

Active Comparator group

Description:

Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH

Treatment:

Other: paracetamol (drug analgesic class1)

Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)

Groupe B without homeopathic treatment

Sham Comparator group

Description:

Conventional treatment : paracetamol (drug analgesic class1)

Treatment:

Other: paracetamol (drug analgesic class1)