NCT04113096

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

November 26, 2018

Last Update Submit

October 3, 2019

Conditions

Stage IV Prostate CancerStage IV Colon CancerStage IV Breast CancerStage IV Cancer of the Cervix

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (22)

  • Haemoglobin Red Cell Test

    Every 8 weeks upto 52 weeks

  • Blood Platelets Tests

    Every 8 weeks upto 52 weeks

  • Blood urea Tests

    Every 8 weeks upto 52 weeks

  • Blood Creatinine

    Every 8 weeks upto 52 weeks

  • Blood Electrolytes

    Every 8 weeks upto 52 weeks

  • +17 more secondary outcomes

Study Arms (4)

Breast Cancer Stage IV

EXPERIMENTAL

Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months

Drug: Dibenzyl trisulphide capsulesDrug: Stage IV Breast Cancer Placebo

Colon Cancer Stage IV

EXPERIMENTAL

Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months

Drug: Dibenzyl trisulphide capsulesDrug: Stage IV: Colon Cancer Placebo

Cervical Cancer Stage IV

EXPERIMENTAL

Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months

Drug: Dibenzyl trisulphide capsulesDrug: Cervical Cancer Stage IV Placebo

Cancer of the Prostate Stage IV

EXPERIMENTAL

Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months

Drug: Dibenzyl trisulphide capsulesDrug: Cancer of the Prostate Placebo

Interventions

Dibenzyl trisulphide capsulesDRUG

20 mg once daily for 6 months

Also known as: Guineahen Weed capsules
Breast Cancer Stage IV
Stage IV Breast Cancer PlaceboDRUG

20 mg once daily for 6 months

Also known as: Placebo
Breast Cancer Stage IV
Stage IV: Colon Cancer PlaceboDRUG

20 mg once daily for 6 months

Also known as: Placebo
Colon Cancer Stage IV
Cervical Cancer Stage IV PlaceboDRUG

20 mg once daily for 6 months

Also known as: Placebo
Cervical Cancer Stage IV
Cancer of the Prostate PlaceboDRUG

20 mg once daily for 6 months

Also known as: Placebo
Cancer of the Prostate Stage IV

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cancer stages less than stage 4
  • Pregnant women
  • Children 0 - 12 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medial Sciences

Kingston, Jamaica

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsColonic NeoplasmsBreast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • LAD Williams

    University of the West Indies, Mona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Horace Fletcher, MBBS/DM

CONTACT

876 927 1145horace.fletcher@uwimona.edu.jm

Gilian Wharfe, MBBS/DM

CONTACT

876.927.1410gilian.wharfe@uwimona.edu.jm

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

October 2, 2019

Study Start

October 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 8, 2019

Record last verified: 2018-10

Locations

JA(1)