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
Interventional, randomised, prospective, monocentric 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:
Describe in patients receiving homeopathic treatment:
Schedule :
277 studies on the registry are indexed under Arthralgia; 54 are open to participants now.
This study's enrollment of 140 is above the median of 73 across 218 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →Institut Jean-Godinot is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Conventional treatment : paracetamol (drug analgesic class1)
Other: paracetamol (drug analgesic class1)
Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
paracetamol (drug analgesic class1)
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
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
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
Rate of onset of pain and joint stiffness
Percentage of patients for whom pain and / or stiffness have occurred.
Time frame: 3 months
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Jean-Godinot