Clinical trial NCT04113096: Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer
Official title: Use of Dibenzyl Trisulphide as a Chemotherapeutic Agent in Stage Four Cancer of the Breast, Prostate, Cervix and Colon
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Stage IV Prostate Cancer
Stage IV Colon Cancer
Stage IV Breast Cancer
Stage IV Cancer of the Cervix
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 104
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prostate Cancer
timeFrame: Every 8 weeks up to 52 weeks
measure: Breast Cancer
timeFrame: Every 8 weeks up to 52 weeks
measure: Colon Cancer
timeFrame: Every 8 weeks up to 52 weeks
measure: Cervical Cancer
timeFrame: Every 8 weeks up to 52 weeks
Secondary outcomes:
measure: Haemoglobin Red Cell Test
timeFrame: Every 8 weeks upto 52 weeks
measure: Blood Platelets Tests
timeFrame: Every 8 weeks upto 52 weeks
measure: Blood urea Tests
timeFrame: Every 8 weeks upto 52 weeks
measure: Blood Creatinine
timeFrame: Every 8 weeks upto 52 weeks
measure: Blood Electrolytes
timeFrame: Every 8 weeks upto 52 weeks
measure: Blood Calcium
timeFrame: Every 8 weeks upto 52 weeks
measure: Blood Phosphorus
timeFrame: Every 8 weeks upto 52 weeks
measure: Prothrombin Test
timeFrame: Every 8 weeks upto 52 weeks
measure: Partial Prothrombin Test
timeFrame: Every 8 weeks upto 52 weeks
measure: White Blood Cell Test
timeFrame: every 8 weeks up to 52 weeks
measure: Computed Tomography (CT) Scan
timeFrame: Every 8 weeks up to 52 weeks
measure: Nuclear bone scintigraphy
timeFrame: every 8 weeks up to 52 weeks
measure: Bilirubin Direct test
timeFrame: Every 8 weeks up to 52 weeks
measure: Bilirubin Indirect test
timeFrame: Every 8 weeks up to 52 weeks
measure: Alkaline Phosphate level test (ALP)
timeFrame: Every 8 weeks up to 52 weeks
measure: Aspartate Aminotransferase test
timeFrame: Every 8 weeks up to 52 weeks
measure: Gamma-glutamyl transferase test
timeFrame: Every 8 weeks up to 52 weeks
measure: Lactate dehydrogenase test
timeFrame: Every 8 weeks up to 52 weeks
measure: Respiration
timeFrame: Every 8 weeks up to 52 weeks
measure: Temperature measurement
timeFrame: Every 8 weeks up to 52 weeks
measure: Pulse
timeFrame: Every 8 weeks up to 52 weeks
measure: Cancer Survival Curves
timeFrame: Every 8 weeks up to 52 weeks
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Faculty of Medial Sciences
Study officials:
affiliation: University of the West Indies, Mona
name: LAD Williams
role: PRINCIPAL_INVESTIGATOR
References: