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Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

Primary Purpose

Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
Jamaica
Study Type
Interventional
Intervention
Dibenzyl trisulphide capsules
Dibenzyl trisulphide capsules
Dibenzyl trisulphide capsules
Dibenzyl trisulphide capsules
Stage IV Breast Cancer Placebo
Stage IV: Colon Cancer Placebo
Cervical Cancer Stage IV Placebo
Cancer of the Prostate Placebo
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Prostate Cancer

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medial SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Breast Cancer Stage IV

Colon Cancer Stage IV

Cervical Cancer Stage IV

Cancer of the Prostate Stage IV

Arm Description

Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months

Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months

Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months

Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months

Outcomes

Primary Outcome Measures

Prostate Cancer
50% change in the Prostate Specific Antigen Response (PSA)
Breast Cancer
Changes in size of the metastatic legions
Colon Cancer
50% change in the Carcinoembryonic Antigen (CEA)
Cervical Cancer
50% change in renal function (Renal output)

Secondary Outcome Measures

Haemoglobin Red Cell Test
Blood - haemoglobin red cell count grams/decilitre
Blood Platelets Tests
Blood; platelet count per microlitre
Blood urea Tests
Blood Urea Nitrogen
Blood Creatinine
Amount of creatinine in the blood
Blood Electrolytes
Amount of electrolytes in the blood
Blood Calcium
Amount of calcium in the blood
Blood Phosphorus
Amount of phosphorus in the blood
Prothrombin Test
Blood prothrombin time (PT).
Partial Prothrombin Test
Partial thromboplastin time( PTT).
White Blood Cell Test
white cell count per microlitre
Computed Tomography (CT) Scan
A pelvis baseline scan and level of metastases quantified by a single radiologist.
Nuclear bone scintigraphy
A bone scintigraphy or X-ray to show number and site of metastases noted
Bilirubin Direct test
Bilirubin direct, mmol per litre
Bilirubin Indirect test
Bilirubin indirect mmol per litre
Alkaline Phosphate level test (ALP)
Amount of Alkaline Phosphate enzyme in blood units per litre
Aspartate Aminotransferase test
Level of the aspartate aminotransferase enzymes in the blood units per litre
Gamma-glutamyl transferase test
Level of the Gamma-glutamyl transferase units per litre
Lactate dehydrogenase test
Level of Lactate dehydrogenase units per litre
Respiration
Number of breaths per minute
Temperature measurement
Temperature; degrees centigrade
Pulse
Pulse-beats per minute
Cancer Survival Curves
Proportion of patients alive after administration of intervention

Full Information

First Posted
November 26, 2018
Last Updated
October 3, 2019
Sponsor
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT04113096
Brief Title
Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer
Official Title
Use of Dibenzyl Trisulphide as a Chemotherapeutic Agent in Stage Four Cancer of the Breast, Prostate, Cervix and Colon
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of The West Indies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer, Stage IV Cancer of the Cervix

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
For each condition there will be two arms of treatment. One arm will receive the investigational product and standard of care the other arm will receive placebo and standard of care
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer Stage IV
Arm Type
Experimental
Arm Description
Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
Arm Title
Colon Cancer Stage IV
Arm Type
Experimental
Arm Description
Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months
Arm Title
Cervical Cancer Stage IV
Arm Type
Experimental
Arm Description
Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Arm Title
Cancer of the Prostate Stage IV
Arm Type
Experimental
Arm Description
Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Intervention Type
Drug
Intervention Name(s)
Dibenzyl trisulphide capsules
Other Intervention Name(s)
Guineahen Weed capsules
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Dibenzyl trisulphide capsules
Other Intervention Name(s)
Guineahen Weed capsules
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Dibenzyl trisulphide capsules
Other Intervention Name(s)
Guineahen Weed capsules
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Dibenzyl trisulphide capsules
Other Intervention Name(s)
Guineahen Weed capsules
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Stage IV Breast Cancer Placebo
Other Intervention Name(s)
Placebo
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Stage IV: Colon Cancer Placebo
Other Intervention Name(s)
Placebo
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Cervical Cancer Stage IV Placebo
Other Intervention Name(s)
Placebo
Intervention Description
20 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Cancer of the Prostate Placebo
Other Intervention Name(s)
Placebo
Intervention Description
20 mg once daily for 6 months
Primary Outcome Measure Information:
Title
Prostate Cancer
Description
50% change in the Prostate Specific Antigen Response (PSA)
Time Frame
Every 8 weeks up to 52 weeks
Title
Breast Cancer
Description
Changes in size of the metastatic legions
Time Frame
Every 8 weeks up to 52 weeks
Title
Colon Cancer
Description
50% change in the Carcinoembryonic Antigen (CEA)
Time Frame
Every 8 weeks up to 52 weeks
Title
Cervical Cancer
Description
50% change in renal function (Renal output)
Time Frame
Every 8 weeks up to 52 weeks
Secondary Outcome Measure Information:
Title
Haemoglobin Red Cell Test
Description
Blood - haemoglobin red cell count grams/decilitre
Time Frame
Every 8 weeks upto 52 weeks
Title
Blood Platelets Tests
Description
Blood; platelet count per microlitre
Time Frame
Every 8 weeks upto 52 weeks
Title
Blood urea Tests
Description
Blood Urea Nitrogen
Time Frame
Every 8 weeks upto 52 weeks
Title
Blood Creatinine
Description
Amount of creatinine in the blood
Time Frame
Every 8 weeks upto 52 weeks
Title
Blood Electrolytes
Description
Amount of electrolytes in the blood
Time Frame
Every 8 weeks upto 52 weeks
Title
Blood Calcium
Description
Amount of calcium in the blood
Time Frame
Every 8 weeks upto 52 weeks
Title
Blood Phosphorus
Description
Amount of phosphorus in the blood
Time Frame
Every 8 weeks upto 52 weeks
Title
Prothrombin Test
Description
Blood prothrombin time (PT).
Time Frame
Every 8 weeks upto 52 weeks
Title
Partial Prothrombin Test
Description
Partial thromboplastin time( PTT).
Time Frame
Every 8 weeks upto 52 weeks
Title
White Blood Cell Test
Description
white cell count per microlitre
Time Frame
every 8 weeks up to 52 weeks
Title
Computed Tomography (CT) Scan
Description
A pelvis baseline scan and level of metastases quantified by a single radiologist.
Time Frame
Every 8 weeks up to 52 weeks
Title
Nuclear bone scintigraphy
Description
A bone scintigraphy or X-ray to show number and site of metastases noted
Time Frame
every 8 weeks up to 52 weeks
Title
Bilirubin Direct test
Description
Bilirubin direct, mmol per litre
Time Frame
Every 8 weeks up to 52 weeks
Title
Bilirubin Indirect test
Description
Bilirubin indirect mmol per litre
Time Frame
Every 8 weeks up to 52 weeks
Title
Alkaline Phosphate level test (ALP)
Description
Amount of Alkaline Phosphate enzyme in blood units per litre
Time Frame
Every 8 weeks up to 52 weeks
Title
Aspartate Aminotransferase test
Description
Level of the aspartate aminotransferase enzymes in the blood units per litre
Time Frame
Every 8 weeks up to 52 weeks
Title
Gamma-glutamyl transferase test
Description
Level of the Gamma-glutamyl transferase units per litre
Time Frame
Every 8 weeks up to 52 weeks
Title
Lactate dehydrogenase test
Description
Level of Lactate dehydrogenase units per litre
Time Frame
Every 8 weeks up to 52 weeks
Title
Respiration
Description
Number of breaths per minute
Time Frame
Every 8 weeks up to 52 weeks
Title
Temperature measurement
Description
Temperature; degrees centigrade
Time Frame
Every 8 weeks up to 52 weeks
Title
Pulse
Description
Pulse-beats per minute
Time Frame
Every 8 weeks up to 52 weeks
Title
Cancer Survival Curves
Description
Proportion of patients alive after administration of intervention
Time Frame
Every 8 weeks up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horace Fletcher, MBBS/DM
Phone
876 927 1145
Email
horace.fletcher@uwimona.edu.jm
First Name & Middle Initial & Last Name or Official Title & Degree
Gilian Wharfe, MBBS/DM
Phone
876.927.1410
Email
gilian.wharfe@uwimona.edu.jm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAD Williams
Organizational Affiliation
University of the West Indies, Mona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medial Sciences
City
Kingston
Country
Jamaica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horace Fletcher, MBBS/DM
Phone
876.927.1145
Email
horace.fletcher@uwimona.edu.jm
First Name & Middle Initial & Last Name & Degree
Gilian Wharfe, MBBS/DM
Phone
876.977.3942
Email
gilian.wharfe@uwimona.edu.jm

12. IPD Sharing Statement

Learn more about this trial

Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

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