An Early Phase 1 interventional study of Dibenzyl trisulphide capsules and Dibenzyl trisulphide capsules in Stage IV Prostate Cancer, Stage IV Colon Cancer and Stage IV Breast Cancer, sponsored by The University of The West Indies. Status unknown at 1 site in Jamaica. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by The University of The West Indies · Early Phase 1, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 104 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The University of The West Indies is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Radiological confirmation of with bone scan or X ray, CT and/or MRI scan Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
Drug: Dibenzyl trisulphide capsules · Drug: Stage IV Breast Cancer Placebo
Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months
Drug: Dibenzyl trisulphide capsules · Drug: Stage IV: Colon Cancer Placebo
Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Drug: Dibenzyl trisulphide capsules · Drug: Cervical Cancer Stage IV Placebo
Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
Drug: Dibenzyl trisulphide capsules · Drug: Cancer of the Prostate Placebo
20 mg once daily for 6 months
Also known as: Guineahen Weed capsules
20 mg once daily for 6 months
Also known as: Guineahen Weed capsules
20 mg once daily for 6 months
Also known as: Guineahen Weed capsules
20 mg once daily for 6 months
Also known as: Guineahen Weed capsules
20 mg once daily for 6 months
Also known as: Placebo
20 mg once daily for 6 months
Also known as: Placebo
20 mg once daily for 6 months
Also known as: Placebo
20 mg once daily for 6 months
Also known as: Placebo
Prostate Cancer
50% change in the Prostate Specific Antigen Response (PSA)
Time frame: Every 8 weeks up to 52 weeks
Breast Cancer
Changes in size of the metastatic legions
Time frame: Every 8 weeks up to 52 weeks
Colon Cancer
50% change in the Carcinoembryonic Antigen (CEA)
Time frame: Every 8 weeks up to 52 weeks
Cervical Cancer
50% change in renal function (Renal output)
Time frame: Every 8 weeks up to 52 weeks
Haemoglobin Red Cell Test
Blood - haemoglobin red cell count grams/decilitre
Time frame: Every 8 weeks upto 52 weeks
Blood Platelets Tests
Blood; platelet count per microlitre
Time frame: Every 8 weeks upto 52 weeks
Blood urea Tests
Blood Urea Nitrogen
Time frame: Every 8 weeks upto 52 weeks
Blood Creatinine
Amount of creatinine in the blood
Time frame: Every 8 weeks upto 52 weeks
Blood Electrolytes
Amount of electrolytes in the blood
Time frame: Every 8 weeks upto 52 weeks
Blood Calcium
Amount of calcium in the blood
Time frame: Every 8 weeks upto 52 weeks
Blood Phosphorus
Amount of phosphorus in the blood
Time frame: Every 8 weeks upto 52 weeks
Prothrombin Test
Blood prothrombin time (PT).
Time frame: Every 8 weeks upto 52 weeks
Partial Prothrombin Test
Partial thromboplastin time( PTT).
Time frame: Every 8 weeks upto 52 weeks
White Blood Cell Test
white cell count per microlitre
Time frame: every 8 weeks up to 52 weeks
Computed Tomography (CT) Scan
A pelvis baseline scan and level of metastases quantified by a single radiologist.
Time frame: Every 8 weeks up to 52 weeks
Nuclear bone scintigraphy
A bone scintigraphy or X-ray to show number and site of metastases noted
Time frame: every 8 weeks up to 52 weeks
Bilirubin Direct test
Bilirubin direct, mmol per litre
Time frame: Every 8 weeks up to 52 weeks
Bilirubin Indirect test
Bilirubin indirect mmol per litre
Time frame: Every 8 weeks up to 52 weeks
Alkaline Phosphate level test (ALP)
Amount of Alkaline Phosphate enzyme in blood units per litre
Time frame: Every 8 weeks up to 52 weeks
Aspartate Aminotransferase test
Level of the aspartate aminotransferase enzymes in the blood units per litre
Time frame: Every 8 weeks up to 52 weeks
Gamma-glutamyl transferase test
Level of the Gamma-glutamyl transferase units per litre
Time frame: Every 8 weeks up to 52 weeks
Lactate dehydrogenase test
Level of Lactate dehydrogenase units per litre
Time frame: Every 8 weeks up to 52 weeks
Respiration
Number of breaths per minute
Time frame: Every 8 weeks up to 52 weeks
Temperature measurement
Temperature; degrees centigrade
Time frame: Every 8 weeks up to 52 weeks
Pulse
Pulse-beats per minute
Time frame: Every 8 weeks up to 52 weeks
Cancer Survival Curves
Proportion of patients alive after administration of intervention
Time frame: Every 8 weeks up to 52 weeks
Started Oct 2018 (actual). Primary completion is estimated for Sep 2020, 23 months after the start.
Of 243 non-industry phase 1 interventional studies under Prostatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 76. This study's planned 23 months is below that.
Counting every sponsor, half of 455 studies reached it within 43 months; a quarter within 23 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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The University of The West Indies