Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

Early Phase 1

• Conditions: Stage IV Breast Cancer; Stage IV Prostate Cancer; Stage IV Cancer of the Cervix; Stage IV Colon Cancer
• Interventions: Drug: Dibenzyl trisulphide capsules; Drug: Cancer of the Prostate Placebo; Drug: Cervical Cancer Stage IV Placebo; Drug: Stage IV Breast Cancer Placebo

• Registration Number: NCT04113096
• Lead Sponsor: The University of The West Indies

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-08
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cancer of the Prostate Stage IV	Cancer of the Prostate Placebo	Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Cervical Cancer Stage IV	Dibenzyl trisulphide capsules	Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Cervical Cancer Stage IV	Cervical Cancer Stage IV Placebo	Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Breast Cancer Stage IV	Dibenzyl trisulphide capsules	Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
Breast Cancer Stage IV	Stage IV Breast Cancer Placebo	Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
Colon Cancer Stage IV	Dibenzyl trisulphide capsules	Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months
Cancer of the Prostate Stage IV	Dibenzyl trisulphide capsules	Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medial Sciences; 🇯🇲 Kingston, Jamaica