NCT04408560

Brief Summary

Interventional, randomised, prospective, monocentric study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

April 4, 2019

Last Update Submit

September 16, 2022

Conditions

Breast Cancer FemaleJoint Pain

Outcome Measures

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)

    3 months

Secondary Outcomes (4)

  • Evolution of joint pain

    6 months

  • Rate of onset of joint pain and stiffness

    3 months

  • Rate of onset of pain and joint stiffness

    3 months

  • Time of onset or aggravation of pain

    6 months

Study Arms (2)

Groupe A with homéopathic treatment

ACTIVE COMPARATOR

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)

Groupe B without homeopathic treatment

SHAM COMPARATOR

Conventional treatment : paracetamol (drug analgesic class1)

Other: paracetamol (drug analgesic class1)

Interventions

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

Rhus toxicodendron 9 CH + Ruta graveolens 5 CH

Groupe A with homéopathic treatment
paracetamol (drug analgesic class1)OTHER

paracetamol (drug analgesic class1)

Groupe A with homéopathic treatmentGroupe B without homeopathic treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philippe GUILBERT

Reims, 51100, France

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • PHILIPPE GUILBERT

    Institut Jean-Godinot

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

May 29, 2020

Study Start

September 13, 2018

Primary Completion

August 27, 2021

Study Completion

March 23, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)