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CompletedNCT04408560ARHOMA2Updated Sep 19, 2022

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

An interventional study of Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules) and paracetamol (drug analgesic class1) in Breast Cancer Female and Joint Pain, sponsored by Institut Jean-Godinot. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-19.

Sponsored by Institut Jean-Godinot · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Interventional, randomised, prospective, monocentric study

Read the 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
02

Conditions studied

  • Breast Cancer Female
  • Joint Pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    Groupe A with homéopathic treatment

    Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH

    Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules) · Other: paracetamol (drug analgesic class1)

  • Sham comparator
    Groupe B without homeopathic treatment

    Conventional treatment : paracetamol (drug analgesic class1)

    Other: paracetamol (drug analgesic class1)

Interventions

  • DrugRhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)

    Rhus toxicodendron 9 CH + Ruta graveolens 5 CH

  • Otherparacetamol (drug analgesic class1)

    paracetamol (drug analgesic class1)

05

What researchers measure

Primary outcomes

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

    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)

    Time frame: 3 months

Secondary outcomes

  1. Evolution of joint pain

    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

    Time frame: 6 months

  2. Rate of onset of joint pain and stiffness

    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)

    Time frame: 3 months

  3. Rate of onset of pain and joint stiffness

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

    Time frame: 3 months

  4. Time of onset or aggravation of pain

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

    Time frame: 6 months

06

Study locations

1 site
  • Philippe GUILBERT
    Reims, 51100, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04408560
Lead sponsor
Institut Jean-Godinot
Responsible party
Sponsor
First posted
May 29, 2020
Start date
Sep 13, 2018
Primary completion
Aug 27, 2021
Completion
Mar 23, 2022
Last update
Sep 19, 2022

Study contacts

PHILIPPE GUILBERT
principal investigator · Institut Jean-Godinot

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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