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Completed

NCT Number: NCT04408560

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

Interventional, randomised, prospective, monocentric study

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Key information

Conditions

Breast Cancer Female Arthralgia Joint Diseases Joint Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Philippe GUILBERT

Reims, 51100, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Rhus toxicodendron 9 CH + Ruta graveolens 5 CH

paracetamol (drug analgesic class1)

Other

paracetamol (drug analgesic class1)

Primary outcomes

  1. Evolution of the score of "most intense pain" during the first 3 months of treatment with AI

    Time frame: 3 months

    Evaluation comparing between the 2 groups the area under the most intense pain curve, measured each week during the first 3 months of AI treatment using the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort)

Secondary outcomes

  1. Evolution of joint pain

    Time frame: 6 months

    variation of different pain scores on the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) : pain severity score corresponding to the average of the 4 questions on pain intensity, and interference score corresponding to the average of the 7 questions on the impact of pain

  2. Rate of onset of joint pain and stiffness

    Time frame: 3 months

    For pain, among patients who answered "no" to the first question of Brief Pain Inventory-Short Form (1 no disconfort up to 10 complet disconfort) to visit 1, percentage of patients who answered "Yes" to 3 months (visit 2)

  3. Rate of onset of pain and joint stiffness

    Time frame: 3 months

    Percentage of patients for whom pain and / or stiffness have occurred.

  4. Time of onset or aggravation of pain

    Time frame: 6 months

    time from which the "most severe pain" score has increased for at least 2 consecutive weeks since the Visit 1 score

Sponsors and collaborators

Lead sponsor

Institut Jean-Godinot

Other

Registry information

Official study 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

Acronym: ARHOMA2

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 29, 2020
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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