Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Radiodermatitis

Breast Diseases

Skin Diseases

Dermatitis

Radiation Injuries

Herbal and Botanical

All Drugs and Chemicals

Belladonna

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

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

Placebo pills of 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 pills

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 placebo pills

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 pills

Aurélie Beneton, MD

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.

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.

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)

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

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

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

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

Radiodermatitis duration will be reported in days.

Radiodermatitis delays will be reported in days.

Number of concomitant treatments will be reported.

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

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

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

Institut de Cancérologie de la Loire

Centre Hospitalier Universitaire de Saint Etienne

Behaviors and Mental Disorders

Quality of Life

A feasibility study examining whether patients with advanced breast cancer would follow a homeopathic protocol for three to six months.

Remedies are sold over the counter without a physician prescription (approved by the Israeli Ministry of Health). No toxicity or side effects are expected to be observed, potencies (dilutions) of substances beyond 7C (7 dilutions, each 1:100) do not contain a sufficient number of molecules of the original material to be pharmacologically active. Since the remedies being used in this trial are diluted at 30c and 200c, levels that are way beyond Avogrado's number, so no original material is expected to be found. This fact was verified utilizing high pressure liquid chromatography (HPLC) method. Due to those facts, most scientists do not accept that these remedies have any biological effects and consign any positive response to the placebo effect.

Homeopathic treatment

Moshe Frenkel, MD

The objective of this study is to conduct a feasibility study at Meir Oncology Institute examining whether patients with advanced breast cancer would follow a homeopathic protocol for three to six months.

The primary aim of the study is to establish if patients with advanced breast cancer in Meir Oncology Institute would follow a regimen of treatment as used by Dr Banerji in India, for six months.

The secondary aim is to observe the quality of life and wellbeing of patients undergoing this protocol

- Homeopathy is a controversial system of care and at the center of the controversy lays the question of whether high dilution remedies can be effective.

There have been only a handful of high quality studies of homeopathy on the treatment of cancer, despite its widespread use for this condition.

In a recent prospective observational study done in Germany with cancer patients in two differently treated cohorts it was observed that an improvement in quality of life was observed in patients taking the addition of homeopathic treatment. In the laboratory, research on homeopathy and cancer that does exist is limited but has some clues for effects that cannot be ignored. A study that was conducted at The University of Texas MD Anderson Cancer Center, revealed that four ultradilute remedies (Carcinosin, Phytolacca, Conium, and Thuja) exerted preferential cytotoxic effects against two breast cancer cell lines, causing cell cycle delay/arrest and apoptosis without affecting the normal mammary epithelial cells. Since patients with advanced breast cancer are the highest CAM users amongst patients affected by cancer, it was thought that a feasibility study with this group of patients, would be a rational first step in proceeding to evaluate this controversial method of care, if it has merit or not.

* The objective of this study is to conduct a feasibility study at Meir Oncology Institute examining whether patients with advanced breast cancer would follow a homeopathic protocol for three to six months. The primary aim of the study is to establish if patients with advanced breast cancer in Meir Oncology Institute would follow homeopathic protocol as used by Dr Banerji in India, for six months. The secondary aim is to observe the quality of life and wellbeing of patients undergoing this protocol.
* Patients with the diagnosis of advanced breast cancer who attend the Meir Oncology Institute clinic will be offered by their treating physician or nurse a fact sheet about this study and will be asked to participate in this protocol. The protocol will be explained to the patient by the research team. If they agree to participate they will be given a consent form to sign, and basic information will be obtained from each patient. This information will include basic demographics (age, marital status, employment , education level) and basic medical information ( Disease status and progress, current symptoms, medications and treatments being used, complementary medicine being used) as well as evaluation of quality of life using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).
* Patients will receive the selected homeopathic remedies (Carcinosin 30C, Phytolacca 200C, and Thuja 30C) with written instructions about the proper use of the remedies. The remedies will be offered to patients in addition to their regular conventional care. Patients that cannot participate in conventional cancer care due to side effects, expected adverse reactions or other reasons that prevent them from utilizing conventional care will be offered to participate in the study, as well. In addition, patients who for their own reasons elect to refuse conventional treatment can be offered to participate in the study in order to keep them in the system and not lose them to alternative untested treatments. Every 4 weeks for the period of 3 months and once at 6 months, a research assistant/ research nurse will contact each participant to review EORTC QLQ- C-30 questionnaire to evaluate quality of life as well as a follow up questionnaire which will verify the actual use of these remedies, perceived problems in taking these remedies, utilization of other therapies, address patients concerns, and document disease progression. A total of 30 patients will be enrolled in this study and their data will be reviewed and analyzed six months after recruitment to the study.

Homeopathic Protocol for Advanced Breast Cancer

The Banerji Protocol for Advanced Breast Cancer- Feasibility Study

Publications, Presentations in international meetings

Investigators will follow patients with advanced breast cancer in Meir Oncology Institute and see if patients would follow a homeopathic treatment protocol as used by Dr Banerji in India, for six months.

Investigators will document the quality of life and wellbeing of patients undergoing this protocol utilizing the EORTC QLQ-C30 (a questionnaire developed to assess the quality of life of cancer patients).

Meir Medical Center

Symptoms and General Pathology

Nausea

Vomiting

Signs and Symptoms, Digestive

Antirheumatic Agents

Sinomenine

12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.

Cocculine®

placebo

RAY-COQUARD Isabelle, MD

The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

The proportion of women with breast cancer treated by chemotherapy (CT) is increasing. CT-induced nausea and vomiting negatively impact patient quality of life.

The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine® administered as an adjunct to conventional treatments (corticosteroids and 5-HT3 receptor antagonists) for the management of nausea induced by a 1st course of adjuvant CT with FAC50, FEC100 or TAC in patients with non-metastatic breast cancer.

Secondary objectives are to test:

* the persistence of Cocculine® efficacy over the 2nd and 3rd CT courses
* the contribution of Cocculine® to the global management of nausea and vomiting during adjuvant CT
* patient compliance with Cocculine® dose.

Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.

Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.

Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women	NCT03753776	Breast Cancer	Placebo pills o... Radium bromatum... Radium bromatum... Radium bromatum...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Homeopathic Protocol for Advanced Breast Cancer	NCT02190539	Breast Cancer	Homeopathic tre...	18 Years -	Meir Medical Center
Homeopathic Protocol for Advanced Breast Cancer	NCT02190539	Breast Cancer	Homeopathic tre...	18 Years -	Meir Medical Center
Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.	NCT00409071	Breast Cancer	Cocculine® placebo	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for homeopathy

Every month we try and update this database with for homeopathy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for homeopathy

Every month we try and update this database with for homeopathy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for homeopathy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.