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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Stage IV | Experimental | Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months |
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| Colon Cancer Stage IV | Experimental | Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months |
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| Cervical Cancer Stage IV | Experimental | Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months |
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| Cancer of the Prostate Stage IV | Experimental | Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dibenzyl trisulphide capsules | Drug | 20 mg once daily for 6 months |
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| 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 |
| 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Horace Fletcher, MBBS/DM | Contact | 876 927 1145 | horace.fletcher@uwimona.edu.jm | |
| Gilian Wharfe, MBBS/DM | Contact | 876.927.1410 | gilian.wharfe@uwimona.edu.jm |
| Name | Affiliation | Role |
|---|---|---|
| LAD Williams | University of the West Indies, Mona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medial Sciences | Recruiting | Kingston | Jamaica |
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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
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double blind
| Dibenzyl trisulphide capsules | Drug | 20 mg once daily for 6 months |
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| Dibenzyl trisulphide capsules | Drug | 20 mg once daily for 6 months |
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| Dibenzyl trisulphide capsules | Drug | 20 mg once daily for 6 months |
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| Stage IV Breast Cancer Placebo | Drug | 20 mg once daily for 6 months |
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| Stage IV: Colon Cancer Placebo | Drug | 20 mg once daily for 6 months |
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| Cervical Cancer Stage IV Placebo | Drug | 20 mg once daily for 6 months |
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| Cancer of the Prostate Placebo | Drug | 20 mg once daily for 6 months |
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| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D003110 | Colonic Neoplasms |
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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