Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer, Stage IV Cancer of the Cervix

Intervention / Treatment
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* Drug: Dibenzyl trisulphide capsules
* Drug: Dibenzyl trisulphide capsules
* Drug: Dibenzyl trisulphide capsules
* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Cancer Stage IV<br>Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months | Drug: Dibenzyl trisulphide capsules<br>* 20 mg once daily for 6 months<br>* Other names: Guineahen Weed capsules;Drug: Stage IV Breast Cancer Placebo<br>* 20 mg once daily for 6 months<br>* Other names: Placebo;|
| Experimental: Colon Cancer Stage IV<br>Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months | Drug: Dibenzyl trisulphide capsules<br>* 20 mg once daily for 6 months<br>* Other names: Guineahen Weed capsules;Drug: Stage IV: Colon Cancer Placebo<br>* 20 mg once daily for 6 months<br>* Other names: Placebo;|
| Experimental: Cervical Cancer Stage IV<br>Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months | Drug: Dibenzyl trisulphide capsules<br>* 20 mg once daily for 6 months<br>* Other names: Guineahen Weed capsules;Drug: Cervical Cancer Stage IV Placebo<br>* 20 mg once daily for 6 months<br>* Other names: Placebo;|
| Experimental: Cancer of the Prostate Stage IV<br>Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months | Drug: Dibenzyl trisulphide capsules<br>* 20 mg once daily for 6 months<br>* Other names: Guineahen Weed capsules;Drug: Cancer of the Prostate Placebo<br>* 20 mg once daily for 6 months<br>* Other names: Placebo;|

What is the study measuring?
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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 |