Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer

NCT ID: NCT04113096

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blind

Study Groups

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Breast Cancer Stage IV

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

Group Type EXPERIMENTAL

Dibenzyl trisulphide capsules

Intervention Type DRUG

20 mg once daily for 6 months

Stage IV Breast Cancer Placebo

Intervention Type DRUG

20 mg once daily for 6 months

Colon Cancer Stage IV

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

Group Type EXPERIMENTAL

Dibenzyl trisulphide capsules

Intervention Type DRUG

20 mg once daily for 6 months

Stage IV: Colon Cancer Placebo

Intervention Type DRUG

20 mg once daily for 6 months

Cervical Cancer Stage IV

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

Group Type EXPERIMENTAL

Dibenzyl trisulphide capsules

Intervention Type DRUG

20 mg once daily for 6 months

Cervical Cancer Stage IV Placebo

Intervention Type DRUG

20 mg once daily for 6 months

Cancer of the Prostate Stage IV

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

Group Type EXPERIMENTAL

Dibenzyl trisulphide capsules

Intervention Type DRUG

20 mg once daily for 6 months

Cancer of the Prostate Placebo

Intervention Type DRUG

20 mg once daily for 6 months

Interventions

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Dibenzyl trisulphide capsules

20 mg once daily for 6 months

Intervention Type DRUG

Dibenzyl trisulphide capsules

20 mg once daily for 6 months

Intervention Type DRUG

Dibenzyl trisulphide capsules

20 mg once daily for 6 months

Intervention Type DRUG

Dibenzyl trisulphide capsules

20 mg once daily for 6 months

Intervention Type DRUG

Stage IV Breast Cancer Placebo

20 mg once daily for 6 months

Intervention Type DRUG

Stage IV: Colon Cancer Placebo

20 mg once daily for 6 months

Intervention Type DRUG

Cervical Cancer Stage IV Placebo

20 mg once daily for 6 months

Intervention Type DRUG

Cancer of the Prostate Placebo

20 mg once daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Guineahen Weed capsules Guineahen Weed capsules Guineahen Weed capsules Guineahen Weed capsules Placebo Placebo Placebo Placebo

Eligibility Criteria

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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

Exclusion Criteria

* Cancer stages less than stage 4
* Pregnant women
* Children 0 - 12 years
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LAD Williams

Role: PRINCIPAL_INVESTIGATOR

University of the West Indies, Mona

Locations

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Faculty of Medial Sciences

Kingston, , Jamaica

Site Status RECRUITING

Countries

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Jamaica

Central Contacts

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Horace Fletcher, MBBS/DM

Role: CONTACT

876 927 1145

Gilian Wharfe, MBBS/DM

Role: CONTACT

876.927.1410

Facility Contacts

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Horace Fletcher, MBBS/DM

Role: primary

876.927.1145

Gilian Wharfe, MBBS/DM

Role: backup

876.977.3942

Other Identifiers

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ECP 250 - 15/16

Identifier Type: -

Identifier Source: org_study_id

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