Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

Stage IV Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113096
• Other study ID #: ECP 250 - 15/16
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2018
• Source: The University of The West Indies
• Contact: Horace Fletcher, MBBS/DM
• Phone: 876 927 1145
• Email: horace.fletcher[@]uwimona.edu.jm
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stage IV Breast Cancer
• Stage IV Cancer of the Cervix
• Stage IV Colon Cancer
• Stage IV Prostate Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Dibenzyl trisulphide capsules
20 mg once daily for 6 months
• Dibenzyl trisulphide capsules
20 mg once daily for 6 months
• Dibenzyl trisulphide capsules
20 mg once daily for 6 months
• Dibenzyl trisulphide capsules
20 mg once daily for 6 months
• Stage IV Breast Cancer Placebo
20 mg once daily for 6 months
• Stage IV: Colon Cancer Placebo
20 mg once daily for 6 months
• Cervical Cancer Stage IV Placebo
20 mg once daily for 6 months
• Cancer of the Prostate Placebo
20 mg once daily for 6 months

Locations

Country	Name	City	State
Jamaica	Faculty of Medial Sciences	Kingston

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Cancer	50% change in the Prostate Specific Antigen Response (PSA)	Every 8 weeks up to 52 weeks
Primary	Breast Cancer	Changes in size of the metastatic legions	Every 8 weeks up to 52 weeks
Primary	Colon Cancer	50% change in the Carcinoembryonic Antigen (CEA)	Every 8 weeks up to 52 weeks
Primary	Cervical Cancer	50% change in renal function (Renal output)	Every 8 weeks up to 52 weeks
Secondary	Haemoglobin Red Cell Test	Blood - haemoglobin red cell count grams/decilitre	Every 8 weeks upto 52 weeks
Secondary	Blood Platelets Tests	Blood; platelet count per microlitre	Every 8 weeks upto 52 weeks
Secondary	Blood urea Tests	Blood Urea Nitrogen	Every 8 weeks upto 52 weeks
Secondary	Blood Creatinine	Amount of creatinine in the blood	Every 8 weeks upto 52 weeks
Secondary	Blood Electrolytes	Amount of electrolytes in the blood	Every 8 weeks upto 52 weeks
Secondary	Blood Calcium	Amount of calcium in the blood	Every 8 weeks upto 52 weeks
Secondary	Blood Phosphorus	Amount of phosphorus in the blood	Every 8 weeks upto 52 weeks
Secondary	Prothrombin Test	Blood prothrombin time (PT).	Every 8 weeks upto 52 weeks
Secondary	Partial Prothrombin Test	Partial thromboplastin time( PTT).	Every 8 weeks upto 52 weeks
Secondary	White Blood Cell Test	white cell count per microlitre	every 8 weeks up to 52 weeks
Secondary	Computed Tomography (CT) Scan	A pelvis baseline scan and level of metastases quantified by a single radiologist.	Every 8 weeks up to 52 weeks
Secondary	Nuclear bone scintigraphy	A bone scintigraphy or X-ray to show number and site of metastases noted	every 8 weeks up to 52 weeks
Secondary	Bilirubin Direct test	Bilirubin direct, mmol per litre	Every 8 weeks up to 52 weeks
Secondary	Bilirubin Indirect test	Bilirubin indirect mmol per litre	Every 8 weeks up to 52 weeks
Secondary	Alkaline Phosphate level test (ALP)	Amount of Alkaline Phosphate enzyme in blood units per litre	Every 8 weeks up to 52 weeks
Secondary	Aspartate Aminotransferase test	Level of the aspartate aminotransferase enzymes in the blood units per litre	Every 8 weeks up to 52 weeks
Secondary	Gamma-glutamyl transferase test	Level of the Gamma-glutamyl transferase units per litre	Every 8 weeks up to 52 weeks
Secondary	Lactate dehydrogenase test	Level of Lactate dehydrogenase units per litre	Every 8 weeks up to 52 weeks
Secondary	Respiration	Number of breaths per minute	Every 8 weeks up to 52 weeks
Secondary	Temperature measurement	Temperature; degrees centigrade	Every 8 weeks up to 52 weeks
Secondary	Pulse	Pulse-beats per minute	Every 8 weeks up to 52 weeks
Secondary	Cancer Survival Curves	Proportion of patients alive after administration of intervention	Every 8 weeks up to 52 weeks