Stage IV Breast Cancer, Stage IV Cancer of the Cervix, Stage IV Colon Cancer, Stage IV Prostate Cancer
Conditions
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.
Interventions
DRUGDibenzyl trisulphide capsules
20 mg once daily for 6 months
DRUGStage IV Breast Cancer Placebo
20 mg once daily for 6 months
DRUGStage IV: Colon Cancer Placebo
20 mg once daily for 6 months
DRUGCervical Cancer Stage IV Placebo
20 mg once daily for 6 months
DRUGCancer of the Prostate Placebo
20 mg once daily for 6 months
Sponsors
The University of The West Indies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind
Intervention 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
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer | Every 8 weeks up to 52 weeks | 50% change in the Prostate Specific Antigen Response (PSA) |
| Breast Cancer | Every 8 weeks up to 52 weeks | Changes in size of the metastatic legions |
| Colon Cancer | Every 8 weeks up to 52 weeks | 50% change in the Carcinoembryonic Antigen (CEA) |
| Cervical Cancer | Every 8 weeks up to 52 weeks | 50% change in renal function (Renal output) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Electrolytes | Every 8 weeks upto 52 weeks | Amount of electrolytes in the blood |
| Blood Calcium | Every 8 weeks upto 52 weeks | Amount of calcium in the blood |
| Blood Phosphorus | Every 8 weeks upto 52 weeks | Amount of phosphorus in the blood |
| 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 |
| Computed Tomography (CT) Scan | Every 8 weeks up to 52 weeks | A pelvis baseline scan and level of metastases quantified by a single radiologist. |
| 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 |
| Haemoglobin Red Cell Test | Every 8 weeks upto 52 weeks | Blood - haemoglobin red cell count grams/decilitre |
| Alkaline Phosphate level test (ALP) | Every 8 weeks up to 52 weeks | Amount of Alkaline Phosphate enzyme in blood units per litre |
| Aspartate Aminotransferase test | Every 8 weeks up to 52 weeks | Level of the aspartate aminotransferase enzymes in the blood units per litre |
| 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 |
| Respiration | Every 8 weeks up to 52 weeks | Number of breaths per minute |
| Temperature measurement | Every 8 weeks up to 52 weeks | Temperature; degrees centigrade |
| Pulse | Every 8 weeks up to 52 weeks | Pulse-beats per minute |
| Cancer Survival Curves | Every 8 weeks up to 52 weeks | Proportion of patients alive after administration of intervention |
| Bilirubin Indirect test | Every 8 weeks up to 52 weeks | Bilirubin indirect mmol per litre |
| Blood Platelets Tests | Every 8 weeks upto 52 weeks | Blood; platelet count per microlitre |
| 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 |
Countries
Jamaica
Contacts
Primary ContactHorace Fletcher, MBBS/DM
Backup ContactGilian Wharfe, MBBS/DM
Outcome results
None listed