Clinical trial NCT02190539: Homeopathic Protocol for Advanced Breast Cancer
Official title: The Banerji Protocol for Advanced Breast Cancer- Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
complementary medicine
homeopathy
quality of life
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: - 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Ability to speak and read Hebrew/English with patients residing in Israel.
* Diagnosis of advanced breast cancer treated and followed in Meir Oncology Institute
* 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.
* 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.
* Consent to participate in this study

Exclusion Criteria:

* Inability to understand the intent of the study and follow the instructions
* Medical condition that would preclude participation in an interview session lasting 15-30 minutes
* Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.

Primary outcomes:
measure: To establish if patients with advanced breast cancer in Meir Oncology Institute would follow a homeopathic treatment protocol as used by Dr Banerji in India, for six months.
timeFrame: Six months
Secondary outcomes:
measure: Observe and verify the quality of life and wellbeing of patients undergoing this protocol
timeFrame: Six months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Institute of Oncology Meir Medical Center
Study officials:
affiliation: Institute of Oncology Meir Medical Center
name: Moshe Frenkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frenkel M, Mishra BM, Sen S, Yang P, Pawlus A, Vence L, Leblanc A, Cohen L, Banerji P, Banerji P. Cytotoxic effects of ultra-diluted remedies on breast cancer cells. Int J Oncol. 2010 Feb;36(2):395-403.