Clinical trial NCT04408560: Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Joint Pain
Lead sponsor: Institut Jean-Godinot
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Evolution of the score of "most intense pain" during the first 3 months of treatment with AI
timeFrame: 3 months
Secondary outcomes:
measure: Evolution of joint pain
timeFrame: 6 months
measure: Rate of onset of joint pain and stiffness
timeFrame: 3 months
measure: Rate of onset of pain and joint stiffness
timeFrame: 3 months
measure: Time of onset or aggravation of pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Philippe GUILBERT
Study officials:
affiliation: Institut Jean-Godinot
name: PHILIPPE GUILBERT
role: PRINCIPAL_INVESTIGATOR
References: