AzTrials
AzTrials

Breast CancerNCT02190539

Homeopathic Protocol for Advanced Breast Cancer

A study testing Homeopathic treatment in people with Breast Cancer, run by Meir Medical Center at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. 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?
Homeopathic treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
Aug 2014to Aug 2019
Phase
Interventional
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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Institute of Oncology Meir Medical Center

    Kfar Saba

Other trials in Israel

About this study

Official title: The Banerji Protocol for Advanced Breast Cancer- Feasibility Study

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

Read the 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.
Conditions
Breast Cancer
Being tested
Homeopathic treatment
Keywords
Breast cancer, complementary medicine, homeopathy, quality of life
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Homeopathic treatmentOther

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

    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.

Study groups in NCT02190539
Study groupRoleWhat they receive
Homeopathic treatmentExperimentalA feasibility study examining whether patients with advanced breast cancer would follow a homeopathic protocol for three to six months.
Receives: Other: Homeopathic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Six months

Secondary outcomes (1)
  1. Observe and verify the quality of life and wellbeing of patients undergoing this protocol

    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).

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2019
  4. Study completionAug 2019

Why it stopped: Not able to recruit patients

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02190539
Sponsor's protocol ID
0050-14-MMC
Status last verified
Aug 2019
First submitted
10 Jul 2014
Last updated
14 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Publications, Presentations in international meetings

Publications

  • 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.

    PubMed 20043074

Questions about this trial

What is this clinical trial studying?

A study testing Homeopathic treatment in people with Breast Cancer, run by Meir Medical Center at 1 site in Israel.

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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Aug 2019. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

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. (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02190539, which also lists 1 linked publication.

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 14 Aug 2019.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in