Breast CancerPhase 3HOMEORADNCT03753776
Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
A Phase 3 study testing Radium bromatum pills and Radium bromatum/Apis mellifica/Belladonna pills in people with Breast Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radium bromatum pills and Radium bromatum/Apis mellifica/Belladonna pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to 5 Apr 2024
- Phase
- Phase 3
- 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
- Major patient;
- Indication of curative intent radiotherapy for breast cancer treated with conservative treatment. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed (additional dose);
- Patient affiliated or entitled to a social security scheme;
- Patient who signed an informed consent form.
Who cannot join
- Pregnant or lactating woman;
- Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent
- Patient followed by a liberal homeopath;
- Patient with bilateral breast cancer;
- Patient with in situ breast cancer;
- Patient with known cognitive impairment;
- Patient with known allergy and / or intolerance and / or malabsorption to fructose, glucose, galactose;
- Patient with a known deficiency in sucrase / isomaltase / lactase.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.
Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.
Homeopathy is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.
Read the detailed description
Breast cancer is the second most frequent cancer worldwide, and the most frequent in France. Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill cancerous cells.
Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women treated. Radiodermatitis could be described with three factors : redness, heat, and edema.
Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and toilet.
Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Placebo pills of Radium bromatum, Radium bromatum pills, Radium bromatum/Apis mellifica/Belladonna placebo pills, Radium bromatum/Apis mellifica/Belladonna pills
- Keywords
- Homeopathy, Radium bromatum, Apis mellifica, Belladonna, Radiodermatitis, Radiotherapy, Prevention, Treatment, Breast cancer
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo pills of Radium bromatumDrug
Also called Radium bromatum placebo
Placebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition
Radium bromatum pillsDrug
Also called Radium bromatum
Homeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition
Radium bromatum/Apis mellifica/Belladonna placebo pillsDrug
Also called Radium bromatum/Apis mellifica/Belladonna placebo
Placebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation
Radium bromatum/Apis mellifica/Belladonna pillsDrug
Also called Radium bromatum/Apis mellifica/Belladonna
Pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation
| Study group | Role | What they receive |
|---|---|---|
| Radium bromatum placebo group | Placebo comparator | Placebo group will receive placebo pills of Radium bromatum during radiotherapy Receives: Drug: Placebo pills of Radium bromatum |
| Radium bromatum group | Experimental | Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy Receives: Drug: Radium bromatum pills |
| Radium bromatum/Apis mellifica/Belladonna placebo group | Placebo comparator | Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis Receives: Drug: Radium bromatum/Apis mellifica/Belladonna placebo pills |
| Radium bromatum/Apis mellifica/Belladonna group | Experimental | Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis Receives: Drug: Radium bromatum/Apis mellifica/Belladonna pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group will be measure with the RTOG (Radiation Therapy Oncology Group) scale. A diminution of 10% between Radium bromatum group and placebo group will be considered as significant
Measured: Week 6
Secondary outcomes (7)
Radiodermatitis frequency
Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.
Measured: Week 6
Radiodermatitis duration
Radiodermatitis duration will be reported in days.
Measured: Week 6
Radiodermatitis delays
Radiodermatitis delays will be reported in days.
Measured: Week 6
Number of concomitant treatments
Number of concomitant treatments will be reported.
Measured: Week 6
Pain measure
Measure of pain will be reported, calculated with a oral scale between 0 and 10.
Measured: Week 6
Level of Quality of life
Level of Quality of life will be measured between 0 to 100 with the EQ-5D questionnaire (european quality of life number 5)
Measured: Week 6
Satisfaction measure
Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start15 Jul 2019
- Primary completion5 Jan 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A first randomization will establish two groups : placebo versus homeopathy (Radium bromatum), and if patients develop a radiodermatitis of grade 2 or higher, a second randomization will take place, with two groups : placebo versus homeopathy (Radium bromatum, Apis mellifica, and Belladonna)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Aurélie Beneton, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753776
- Sponsor's protocol ID
- 2018-0601
- Other IDs
- 2018-002406-32, 2018
- Acronym
- HOMEORAD
- Status last verified
- Apr 2025
- First submitted
- 22 Nov 2018
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
- ClinicalTrials.gov ID
- NCT03753776
- Acronym / sponsor ID
- HOMEORAD / 2018-0601
- Conditions
- Breast Cancer
- Keywords
- Homeopathy, Radium bromatum, Apis mellifica, Belladonna, Radiodermatitis, Radiotherapy, Prevention, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 27 Nov 2018 (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.
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.
Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.
Homeopathy is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.
Detailed description
Breast cancer is the second most frequent cancer worldwide, and the most frequent in France. Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill cancerous cells.
Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women treated. Radiodermatitis could be described with three factors : redness, heat, and edema.
Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and toilet.
Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A first randomization will establish two groups : placebo versus homeopathy (Radium bromatum), and if patients develop a radiodermatitis of grade 2 or higher, a second randomization will take place, with two groups : placebo versus homeopathy (Radium bromatum, Apis mellifica, and Belladonna)
| Arm | Type | Receives |
|---|---|---|
| Radium bromatum placebo group | Placebo comparator | Drug: Placebo pills of Radium bromatumPlacebo group will receive placebo pills of Radium bromatum during radiotherapy |
| Radium bromatum group | Experimental | Drug: Radium bromatum pillsRadium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy |
| Radium bromatum/Apis mellifica/Belladonna placebo group | Placebo comparator | Drug: Radium bromatum/Apis mellifica/Belladonna placebo pillsPlacebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis |
| Radium bromatum/Apis mellifica/Belladonna group | Experimental | Drug: Radium bromatum/Apis mellifica/Belladonna pillsRadium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient;
- Indication of curative intent radiotherapy for breast cancer treated with conservative treatment. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed (additional dose);
- Patient affiliated or entitled to a social security scheme;
- Patient who signed an informed consent form.
Key exclusion criteria (8 listed)
- Pregnant or lactating woman;
- Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent
- Patient followed by a liberal homeopath;
- Patient with bilateral breast cancer;
- Patient with in situ breast cancer;
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 |
|---|---|---|
| Placebo pills of Radium bromatumAlso: Radium bromatum placeboPlacebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition | Drug | Radium bromatum placebo group |
| Radium bromatum pillsAlso: Radium bromatumHomeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition | Drug | Radium bromatum group |
| Radium bromatum/Apis mellifica/Belladonna placebo pillsAlso: Radium bromatum/Apis mellifica/Belladonna placeboPlacebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation | Drug | Radium bromatum/Apis mellifica/Belladonna placebo group |
| Radium bromatum/Apis mellifica/Belladonna pillsAlso: Radium bromatum/Apis mellifica/BelladonnaPills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation | Drug | Radium bromatum/Apis mellifica/Belladonna group |
Primary outcome
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group
Time frame: Week 6
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group will be measure with the RTOG (Radiation Therapy Oncology Group) scale. A diminution of 10% between Radium bromatum group and placebo group will be considered as significant
7 secondary outcomes
Radiodermatitis frequency
Time frame: Week 6
Radiodermatitis duration
Time frame: Week 6
Radiodermatitis delays
Time frame: Week 6
Number of concomitant treatments
Time frame: Week 6
Pain measure
Time frame: Week 6
Level of Quality of life
Time frame: Week 6
Satisfaction measure
Time frame: Week 6
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 9 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Aurélie Beneton, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radium bromatum pills and Radium bromatum/Apis mellifica/Belladonna pills in people with Breast Cancer, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 8 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 9 Apr 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group (time frame: Week 6). 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 9 Apr 2025.