Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

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: Unknown
• Conditions: Stage IV Breast Cancer; Stage IV Prostate Cancer; Stage IV Colon Cancer; Stage IV Cancer of the Cervix
• Intervention / Treatment: Drug: Dibenzyl trisulphide capsules; Drug: Stage IV Breast Cancer Placebo; Drug: Stage IV: Colon Cancer Placebo; Drug: Cervical Cancer Stage IV Placebo; Drug: Cancer of the Prostate Placebo

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: Interventional
• Enrollment (Anticipated): 104
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Horace Fletcher, MBBS/DM; Phone Number: 876 927 1145; Email: horace.fletcher@uwimona.edu.jm
• Study Contact Backup: Name: Gilian Wharfe, MBBS/DM; Phone Number: 876.927.1410; Email: gilian.wharfe@uwimona.edu.jm

Study Locations

• Jamaica
  • Kingston, Jamaica
    • Recruiting
    • Faculty of Medial Sciences
    • Contact: Horace Fletcher, MBBS/DM; Phone Number: 876.927.1145; Email: horace.fletcher@uwimona.edu.jm
    • Contact: Gilian Wharfe, MBBS/DM; Phone Number: 876.977.3942; Email: gilian.wharfe@uwimona.edu.jm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Prostate Cancer	50% change in the Prostate Specific Antigen Response (PSA)	Every 8 weeks up to 52 weeks
Breast Cancer	Changes in size of the metastatic legions	Every 8 weeks up to 52 weeks
Colon Cancer	50% change in the Carcinoembryonic Antigen (CEA)	Every 8 weeks up to 52 weeks
Cervical Cancer	50% change in renal function (Renal output)	Every 8 weeks up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin Red Cell Test	Blood - haemoglobin red cell count grams/decilitre	Every 8 weeks upto 52 weeks
Blood Platelets Tests	Blood; platelet count per microlitre	Every 8 weeks upto 52 weeks
Blood urea Tests	Blood Urea Nitrogen	Every 8 weeks upto 52 weeks
Blood Creatinine	Amount of creatinine in the blood	Every 8 weeks upto 52 weeks
Blood Electrolytes	Amount of electrolytes in the blood	Every 8 weeks upto 52 weeks
Blood Calcium	Amount of calcium in the blood	Every 8 weeks upto 52 weeks
Blood Phosphorus	Amount of phosphorus in the blood	Every 8 weeks upto 52 weeks
Prothrombin Test	Blood prothrombin time (PT).	Every 8 weeks upto 52 weeks
Partial Prothrombin Test	Partial thromboplastin time( PTT).	Every 8 weeks upto 52 weeks
White Blood Cell Test	white cell count per microlitre	every 8 weeks up to 52 weeks
Computed Tomography (CT) Scan	A pelvis baseline scan and level of metastases quantified by a single radiologist.	Every 8 weeks up to 52 weeks
Nuclear bone scintigraphy	A bone scintigraphy or X-ray to show number and site of metastases noted	every 8 weeks up to 52 weeks
Bilirubin Direct test	Bilirubin direct, mmol per litre	Every 8 weeks up to 52 weeks
Bilirubin Indirect test	Bilirubin indirect mmol per litre	Every 8 weeks up to 52 weeks
Alkaline Phosphate level test (ALP)	Amount of Alkaline Phosphate enzyme in blood units per litre	Every 8 weeks up to 52 weeks
Aspartate Aminotransferase test	Level of the aspartate aminotransferase enzymes in the blood units per litre	Every 8 weeks up to 52 weeks
Gamma-glutamyl transferase test	Level of the Gamma-glutamyl transferase units per litre	Every 8 weeks up to 52 weeks
Lactate dehydrogenase test	Level of Lactate dehydrogenase units per litre	Every 8 weeks up to 52 weeks
Respiration	Number of breaths per minute	Every 8 weeks up to 52 weeks
Temperature measurement	Temperature; degrees centigrade	Every 8 weeks up to 52 weeks
Pulse	Pulse-beats per minute	Every 8 weeks up to 52 weeks
Cancer Survival Curves	Proportion of patients alive after administration of intervention	Every 8 weeks up to 52 weeks

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: LAD Williams, University of the West Indies, mona

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID 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