NCT02190539

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

5 years

First QC Date

July 10, 2014

Last Update Submit

August 12, 2019

Conditions

Breast Cancer

Keywords

Breast cancercomplementary medicinehomeopathyquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Six months

Secondary Outcomes (1)

  • Observe and verify the quality of life and wellbeing of patients undergoing this protocol

    Six months

Study Arms (1)

Homeopathic treatment

EXPERIMENTAL

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

Other: Homeopathic treatment

Interventions

Homeopathic treatmentOTHER

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.

Also known as: A combined treatment of three homeopathic remedies:, Phytolacca 200C, Thuja 30C, Carcinosin 30c
Homeopathic treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20043074RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Moshe Frenkel, MD

    Institute of Oncology Meir Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 15, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Publications, Presentations in international meetings

Locations

IL(1)