Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer - Female
  • Joint Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 g...

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: 01/09/2020 (duration to possibly adapt in order to obtain the number of required patients) End date of follow-up: 01/03/2021 Study report: 01/09/2021

Tracking Information

NCT #
NCT04408560
Collaborators
Not Provided
Investigators
Principal Investigator: PHILIPPE GUILBERT Institut Jean-Godinot