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

NCT ID: NCT04408560

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2022-03-23

Brief Summary

Interventional, randomised, prospective, monocentric study

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

Conditions

Breast Cancer Female; Joint Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Groupe A with homéopathic treatment

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Rhus toxicodendron 9 CH + Ruta graveolens 5 CH

paracetamol (drug analgesic class1)

Intervention Type: OTHER

paracetamol (drug analgesic class1)

Groupe B without homeopathic treatment

Conventional treatment : paracetamol (drug analgesic class1)

Group Type: SHAM_COMPARATOR

paracetamol (drug analgesic class1)

Intervention Type: OTHER

paracetamol (drug analgesic class1)

Interventions

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

Rhus toxicodendron 9 CH + Ruta graveolens 5 CH

Intervention Type: DRUG

paracetamol (drug analgesic class1)

paracetamol (drug analgesic class1)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Jean-Godinot

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PHILIPPE GUILBERT

Role: PRINCIPAL_INVESTIGATOR

Institut Jean-Godinot

Locations

Philippe GUILBERT

Reims, , France

Countries

France

Other Identifiers

2018-A01019-46

Identifier Type: -

Identifier Source: org_study_id