Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 3:57 AM
Study NCT ID:
NCT04408560
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer
Sponsor:
Institut Jean-Godinot
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARHOMA2
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: