Breast Cancer FemaleARHOMA2NCT04408560
Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer
A study testing Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules) and paracetamol (drug analgesic class1) in people with Breast Cancer Female and Joint Pain, run by Institut Jean-Godinot at 1 site in France.
Trial summary
Interventional, randomised, prospective, monocentric study Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Joint Pain
- What is being tested?
- Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules) and paracetamol (drug analgesic class1)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2018to 23 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Breast Cancer Female, Joint Pain
- Being tested
- Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules), paracetamol (drug analgesic class1)
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Groupe A with homéopathic treatment | Active comparator | Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH Receives: 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) Receives: Other: paracetamol (drug analgesic class1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (4)
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
Measured: 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)
Measured: 3 months
Rate of onset of pain and joint stiffness
Percentage of patients for whom pain and / or stiffness have occurred.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start13 Sep 2018
- Primary completion27 Aug 2021
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jean-Godinot
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PHILIPPE GUILBERT, Principal investigator, Institut Jean-Godinot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408560
- Sponsor's protocol ID
- 2018-A01019-46
- Acronym
- ARHOMA2
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2019
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04408560
- Acronym / sponsor ID
- ARHOMA2 / 2018-A01019-46
- Conditions
- Breast Cancer Female, Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Institut Jean-GodinotUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional, randomised, prospective, monocentric study
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groupe A with homéopathic treatment | Active comparator | Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules), Other: paracetamol (drug analgesic class1)Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH |
| Groupe B without homeopathic treatment | Sham comparator | Other: paracetamol (drug analgesic class1)Conventional treatment : paracetamol (drug analgesic class1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)Rhus toxicodendron 9 CH + Ruta graveolens 5 CH | Drug | Groupe A with homéopathic treatment |
| paracetamol (drug analgesic class1)paracetamol (drug analgesic class1) | Other | Groupe A with homéopathic treatment, Groupe B without homeopathic treatment |
Primary outcome
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)
4 secondary outcomes
Evolution of joint pain
Time frame: 6 months
Rate of onset of joint pain and stiffness
Time frame: 3 months
Rate of onset of pain and joint stiffness
Time frame: 3 months
Time of onset or aggravation of pain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PHILIPPE GUILBERT principal investigator
Institut Jean-Godinot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules) and paracetamol (drug analgesic class1) in people with Breast Cancer Female and Joint Pain, run by Institut Jean-Godinot at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the score of "most intense pain" during the first 3 months of treatment with AI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.