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

  • STATUS
    Recruiting
  • participants needed
    140
  • sponsor
    Institut Jean-Godinot
Updated on 19 February 2024
cancer
rheumatism
lupus
breast cancer
vitamin d
metastatic breast cancer
analgesics
narcotics
arthritis
narcotic
stage iv breast cancer
ankylosing spondylitis
homeopathic
ruta graveolens
adjuvant
HER2
rhus toxicodendron
narcotic drugs

Summary

Interventional, randomised, prospective, monocentric study

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: 01/09/2020 (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

Details
Condition Arthralgia, Pain, Pain, Breast Cancer Female
Age 18years - 100years
Treatment Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules), paracetamol (drug analgesic class1)
Clinical Study IdentifierNCT04408560
SponsorInstitut Jean-Godinot
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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