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Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women (HOMEORAD)

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Placebo pills of Radium bromatum

Radium bromatum pills

Radium bromatum/Apis mellifica/Belladonna placebo pills

Radium bromatum/Apis mellifica/Belladonna pills

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Homeopathy, Radium bromatum, Apis mellifica, Belladonna, Radiodermatitis, Radiotherapy, Prevention, Treatment, Breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Radium bromatum placebo group

Radium bromatum group

Radium bromatum/Apis mellifica/Belladonna placebo group

Radium bromatum/Apis mellifica/Belladonna group

Arm Description

Placebo group will receive placebo pills of Radium bromatum during radiotherapy

Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy

Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis

Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Radiodermatitis frequency

Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.

Radiodermatitis duration

Radiodermatitis duration will be reported in days.

Radiodermatitis delays

Radiodermatitis delays will be reported in days.

Number of concomitant treatments

Number of concomitant treatments will be reported.

Pain measure

Measure of pain will be reported, calculated with a oral scale between 0 and 10.

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)

Satisfaction measure

Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)

Full Information

NCT ID

NCT03753776

First Posted

November 22, 2018

Last Updated

May 4, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

1. Study Identification

Unique Protocol Identification Number

NCT03753776

Brief Title

Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

Acronym

HOMEORAD

Official Title

Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Homeopathy, Radium bromatum, Apis mellifica, Belladonna, Radiodermatitis, Radiotherapy, Prevention, Treatment, Breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)

Allocation

Randomized

Enrollment

232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radium bromatum placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo group will receive placebo pills of Radium bromatum during radiotherapy

Arm Title

Radium bromatum group

Arm Type

Experimental

Arm Description

Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy

Arm Title

Radium bromatum/Apis mellifica/Belladonna placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis

Arm Title

Radium bromatum/Apis mellifica/Belladonna group

Arm Type

Experimental

Arm Description

Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis

Intervention Type

Drug

Intervention Name(s)

Placebo pills of Radium bromatum

Other Intervention Name(s)

Radium bromatum placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Radium bromatum pills

Other Intervention Name(s)

Radium bromatum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Radium bromatum/Apis mellifica/Belladonna placebo pills

Other Intervention Name(s)

Radium bromatum/Apis mellifica/Belladonna placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Radium bromatum/Apis mellifica/Belladonna pills

Other Intervention Name(s)

Radium bromatum/Apis mellifica/Belladonna

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group

Description

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Radiodermatitis frequency

Description

Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.

Time Frame

Week 6

Title

Radiodermatitis duration

Description

Radiodermatitis duration will be reported in days.

Time Frame

Week 6

Title

Radiodermatitis delays

Description

Radiodermatitis delays will be reported in days.

Time Frame

Week 6

Title

Number of concomitant treatments

Description

Number of concomitant treatments will be reported.

Time Frame

Week 6

Title

Pain measure

Description

Measure of pain will be reported, calculated with a oral scale between 0 and 10.

Time Frame

Week 6

Title

Level of Quality of life

Description

Level of Quality of life will be measured between 0 to 100 with the EQ-5D questionnaire (european quality of life number 5)

Time Frame

Week 6

Title

Satisfaction measure

Description

Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)

Time Frame

Week 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aurélie Beneton, MD

Phone

0477917136

Ext

+33

aurelie.beneton@chu-st-etienne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Mathilde Gras, MsC

Phone

0477917136

Ext

+33

mathilde.gras@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aurélie Beneton, MD

Organizational Affiliation

CHU de Saint-Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Saint-Etienne

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurélie Beneton, MD

First Name & Middle Initial & Last Name & Degree

Aurélie Beneton, MD

First Name & Middle Initial & Last Name & Degree

Stéphanie Morisson, MD

First Name & Middle Initial & Last Name & Degree

Christelle Brosse, MD

First Name & Middle Initial & Last Name & Degree

Jane-Chloé Trone, MD

First Name & Middle Initial & Last Name & Degree

Anne Bareille, MD

First Name & Middle Initial & Last Name & Degree

Thomas Reynaud, MD

First Name & Middle Initial & Last Name & Degree

Grégoire Pigné, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

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