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NCT04408560 | COMPLETED | Breast Cancer Female

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

Institut Jean-Godinot

Brief Summary:

Interventional, randomised, prospective, monocentric study

Condition or disease

Breast Cancer Female

Joint Pain

Intervention/treatment

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

paracetamol (drug analgesic class1)

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 140 participants
Masking : SINGLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2018-09-13
Estimated Primary Completion Date : 2021-08-27
Estimated Study Completion Date : 2022-03-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer

Location Details

NCT04408560

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How to Participate

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Locations

Not yet recruiting

France,

Philippe Guilbert

Reims, France, 51100