Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

October 3, 2019 updated by: The University of The West Indies

Use of Dibenzyl Trisulphide as a Chemotherapeutic Agent in Stage Four Cancer of the Breast, Prostate, Cervix and Colon

This study is being done to find the effect of Dibenzyl Trisulphide (active ingredient in Guinea Hen Weed in combination in patients with stage four cancer of the breast, prostate, cervix and colon.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There have been many claims of the value of Guinea Hen weed in the treatment of different cancers. The preparation is readily available and used locally. The team proposes to validate the studies done on cancer cell lines by conducting a clinical trial to determine the clinical benefit in advanced and metastatic cancers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: Greater than 12 years.
  • Documented histologic evidence of cancer
  • Staged as stage IV
  • World Health Organization (WHO) Performance Status of between 0 and 2

  • Radiological confirmation of metastases with bone scan or X ray, CT and/or MRI scan Exclusion Criteria

    • Cancer stages less than stage 4
    • Pregnant women
    • Children 0 - 12 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Breast Cancer Stage IV
Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
Drug: Dibenzyl trisulphide capsules
20 mg once daily for 6 months
Other Names:
  • Guineahen Weed capsules
Drug: Stage IV Breast Cancer Placebo
20 mg once daily for 6 months
Other Names:
  • Placebo
Experimental: Colon Cancer Stage IV
Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months
Drug: Dibenzyl trisulphide capsules
20 mg once daily for 6 months
Other Names:
  • Guineahen Weed capsules
Drug: Stage IV: Colon Cancer Placebo
20 mg once daily for 6 months
Other Names:
  • Placebo
Experimental: Cervical Cancer Stage IV
Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Drug: Dibenzyl trisulphide capsules
20 mg once daily for 6 months
Other Names:
  • Guineahen Weed capsules
Drug: Cervical Cancer Stage IV Placebo
20 mg once daily for 6 months
Other Names:
  • Placebo
Experimental: Cancer of the Prostate Stage IV
Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Drug: Dibenzyl trisulphide capsules
20 mg once daily for 6 months
Other Names:
  • Guineahen Weed capsules
Drug: Cancer of the Prostate Placebo
20 mg once daily for 6 months
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prostate Cancer
Time Frame: Every 8 weeks up to 52 weeks
50% change in the Prostate Specific Antigen Response (PSA)
Every 8 weeks up to 52 weeks
Breast Cancer
Time Frame: Every 8 weeks up to 52 weeks
Changes in size of the metastatic legions
Every 8 weeks up to 52 weeks
Colon Cancer
Time Frame: Every 8 weeks up to 52 weeks
50% change in the Carcinoembryonic Antigen (CEA)
Every 8 weeks up to 52 weeks
Cervical Cancer
Time Frame: Every 8 weeks up to 52 weeks
50% change in renal function (Renal output)
Every 8 weeks up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Haemoglobin Red Cell Test
Time Frame: Every 8 weeks upto 52 weeks
Blood - haemoglobin red cell count grams/decilitre
Every 8 weeks upto 52 weeks
Blood Platelets Tests
Time Frame: Every 8 weeks upto 52 weeks
Blood; platelet count per microlitre
Every 8 weeks upto 52 weeks
Blood urea Tests
Time Frame: Every 8 weeks upto 52 weeks
Blood Urea Nitrogen
Every 8 weeks upto 52 weeks
Blood Creatinine
Time Frame: Every 8 weeks upto 52 weeks
Amount of creatinine in the blood
Every 8 weeks upto 52 weeks
Blood Electrolytes
Time Frame: Every 8 weeks upto 52 weeks
Amount of electrolytes in the blood
Every 8 weeks upto 52 weeks
Blood Calcium
Time Frame: Every 8 weeks upto 52 weeks
Amount of calcium in the blood
Every 8 weeks upto 52 weeks
Blood Phosphorus
Time Frame: Every 8 weeks upto 52 weeks
Amount of phosphorus in the blood
Every 8 weeks upto 52 weeks
Prothrombin Test
Time Frame: Every 8 weeks upto 52 weeks
Blood prothrombin time (PT).
Every 8 weeks upto 52 weeks
Partial Prothrombin Test
Time Frame: Every 8 weeks upto 52 weeks
Partial thromboplastin time( PTT).
Every 8 weeks upto 52 weeks
White Blood Cell Test
Time Frame: every 8 weeks up to 52 weeks
white cell count per microlitre
every 8 weeks up to 52 weeks
Computed Tomography (CT) Scan
Time Frame: Every 8 weeks up to 52 weeks
A pelvis baseline scan and level of metastases quantified by a single radiologist.
Every 8 weeks up to 52 weeks
Nuclear bone scintigraphy
Time Frame: every 8 weeks up to 52 weeks
A bone scintigraphy or X-ray to show number and site of metastases noted
every 8 weeks up to 52 weeks
Bilirubin Direct test
Time Frame: Every 8 weeks up to 52 weeks
Bilirubin direct, mmol per litre
Every 8 weeks up to 52 weeks
Bilirubin Indirect test
Time Frame: Every 8 weeks up to 52 weeks
Bilirubin indirect mmol per litre
Every 8 weeks up to 52 weeks
Alkaline Phosphate level test (ALP)
Time Frame: Every 8 weeks up to 52 weeks
Amount of Alkaline Phosphate enzyme in blood units per litre
Every 8 weeks up to 52 weeks
Aspartate Aminotransferase test
Time Frame: Every 8 weeks up to 52 weeks
Level of the aspartate aminotransferase enzymes in the blood units per litre
Every 8 weeks up to 52 weeks
Gamma-glutamyl transferase test
Time Frame: Every 8 weeks up to 52 weeks
Level of the Gamma-glutamyl transferase units per litre
Every 8 weeks up to 52 weeks
Lactate dehydrogenase test
Time Frame: Every 8 weeks up to 52 weeks
Level of Lactate dehydrogenase units per litre
Every 8 weeks up to 52 weeks
Respiration
Time Frame: Every 8 weeks up to 52 weeks
Number of breaths per minute
Every 8 weeks up to 52 weeks
Temperature measurement
Time Frame: Every 8 weeks up to 52 weeks
Temperature; degrees centigrade
Every 8 weeks up to 52 weeks
Pulse
Time Frame: Every 8 weeks up to 52 weeks
Pulse-beats per minute
Every 8 weeks up to 52 weeks
Cancer Survival Curves
Time Frame: Every 8 weeks up to 52 weeks
Proportion of patients alive after administration of intervention
Every 8 weeks up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of The West Indies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LAD Williams, University of the West Indies, Mona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECP 250 - 15/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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