Stage IV Prostate CancerEarly Phase 1NCT04113096
Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer
A Early Phase 1 study testing Dibenzyl trisulphide capsules in people with Stage IV Prostate Cancer and Stage IV Colon Cancer, run by The University of The West Indies at 1 site in Jamaica.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer
- What is being tested?
- Dibenzyl trisulphide capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Oct 2018to 30 Sep 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
Faculty of Medial Sciences
Kingston
Horace Fletcher, MBBS/DM, 876.927.1145, horace.fletcher@uwimona.edu.jm
Gilian Wharfe, MBBS/DM, 876.977.3942, gilian.wharfe@uwimona.edu.jm
About this study
Official title: Use of Dibenzyl Trisulphide as a Chemotherapeutic Agent in Stage Four Cancer of the Breast, Prostate, Cervix and Colon
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.
Read the 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.
- Conditions
- Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer, Stage IV Cancer of the Cervix
- Being tested
- Dibenzyl trisulphide capsules, Stage IV Breast Cancer Placebo, Stage IV: Colon Cancer Placebo, Cervical Cancer Stage IV Placebo, Cancer of the Prostate Placebo
- Medical subject headings
- Prostatic Neoplasms, Colonic Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dibenzyl trisulphide capsulesDrug
Also called Guineahen Weed capsules
20 mg once daily for 6 months
Dibenzyl trisulphide capsulesDrug
Also called Guineahen Weed capsules
20 mg once daily for 6 months
Dibenzyl trisulphide capsulesDrug
Also called Guineahen Weed capsules
20 mg once daily for 6 months
Dibenzyl trisulphide capsulesDrug
Also called Guineahen Weed capsules
20 mg once daily for 6 months
Stage IV Breast Cancer PlaceboDrug
Also called Placebo
20 mg once daily for 6 months
Stage IV: Colon Cancer PlaceboDrug
Also called Placebo
20 mg once daily for 6 months
Cervical Cancer Stage IV PlaceboDrug
Also called Placebo
20 mg once daily for 6 months
Cancer of the Prostate PlaceboDrug
Also called Placebo
20 mg once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Stage IV | Experimental | Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months Receives: Drug: Dibenzyl trisulphide capsules; Drug: Stage IV Breast Cancer Placebo |
| Colon Cancer Stage IV | Experimental | Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months Receives: Drug: Dibenzyl trisulphide capsules; Drug: 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 Receives: Drug: Dibenzyl trisulphide capsules; Drug: 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 Receives: Drug: Dibenzyl trisulphide capsules; Drug: Cancer of the Prostate Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Cancer
50% change in the Prostate Specific Antigen Response (PSA)
Measured: Every 8 weeks up to 52 weeks
Breast Cancer
Changes in size of the metastatic legions
Measured: Every 8 weeks up to 52 weeks
Colon Cancer
50% change in the Carcinoembryonic Antigen (CEA)
Measured: Every 8 weeks up to 52 weeks
Cervical Cancer
50% change in renal function (Renal output)
Measured: Every 8 weeks up to 52 weeks
Secondary outcomes (22)
Haemoglobin Red Cell Test
Blood - haemoglobin red cell count grams/decilitre
Measured: Every 8 weeks upto 52 weeks
Blood Platelets Tests
Blood; platelet count per microlitre
Measured: Every 8 weeks upto 52 weeks
Blood urea Tests
Blood Urea Nitrogen
Measured: Every 8 weeks upto 52 weeks
Blood Creatinine
Amount of creatinine in the blood
Measured: Every 8 weeks upto 52 weeks
Blood Electrolytes
Amount of electrolytes in the blood
Measured: Every 8 weeks upto 52 weeks
Blood Calcium
Amount of calcium in the blood
Measured: Every 8 weeks upto 52 weeks
Blood Phosphorus
Amount of phosphorus in the blood
Measured: Every 8 weeks upto 52 weeks
Prothrombin Test
Blood prothrombin time (PT).
Measured: Every 8 weeks upto 52 weeks
Partial Prothrombin Test
Partial thromboplastin time( PTT).
Measured: Every 8 weeks upto 52 weeks
White Blood Cell Test
white cell count per microlitre
Measured: every 8 weeks up to 52 weeks
Computed Tomography (CT) Scan
A pelvis baseline scan and level of metastases quantified by a single radiologist.
Measured: Every 8 weeks up to 52 weeks
Nuclear bone scintigraphy
A bone scintigraphy or X-ray to show number and site of metastases noted
Measured: every 8 weeks up to 52 weeks
Bilirubin Direct test
Bilirubin direct, mmol per litre
Measured: Every 8 weeks up to 52 weeks
Bilirubin Indirect test
Bilirubin indirect mmol per litre
Measured: Every 8 weeks up to 52 weeks
Alkaline Phosphate level test (ALP)
Amount of Alkaline Phosphate enzyme in blood units per litre
Measured: Every 8 weeks up to 52 weeks
Aspartate Aminotransferase test
Level of the aspartate aminotransferase enzymes in the blood units per litre
Measured: Every 8 weeks up to 52 weeks
Gamma-glutamyl transferase test
Level of the Gamma-glutamyl transferase units per litre
Measured: Every 8 weeks up to 52 weeks
Lactate dehydrogenase test
Level of Lactate dehydrogenase units per litre
Measured: Every 8 weeks up to 52 weeks
Respiration
Number of breaths per minute
Measured: Every 8 weeks up to 52 weeks
Temperature measurement
Temperature; degrees centigrade
Measured: Every 8 weeks up to 52 weeks
Pulse
Pulse-beats per minute
Measured: Every 8 weeks up to 52 weeks
Cancer Survival Curves
Proportion of patients alive after administration of intervention
Measured: Every 8 weeks up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Oct 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAD Williams, Principal investigator, University of the West Indies, Mona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113096
- Sponsor's protocol ID
- ECP 250 - 15/16
- Status last verified
- Oct 2018
- First submitted
- 26 Nov 2018
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dibenzyl Trisulphide as a Chemotherapeutic Agent in Stage Four Cancer of the Breast, Prostate, Cervix and Colon
- ClinicalTrials.gov ID
- NCT04113096
- Acronym / sponsor ID
- ECP 250 - 15/16
- Conditions
- Stage IV Prostate Cancer, Stage IV Colon Cancer, Stage IV Breast Cancer, Stage IV Cancer of the Cervix
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Stage IV | Experimental | Drug: Dibenzyl trisulphide capsules, Drug: Stage IV Breast Cancer PlaceboStage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months |
| Colon Cancer Stage IV | Experimental | Drug: Dibenzyl trisulphide capsules, Drug: Stage IV: Colon Cancer PlaceboStage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months |
| Cervical Cancer Stage IV | Experimental | Drug: Dibenzyl trisulphide capsules, Drug: Cervical Cancer Stage IV PlaceboStage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months |
| Cancer of the Prostate Stage IV | Experimental | Drug: Dibenzyl trisulphide capsules, Drug: Cancer of the Prostate PlaceboStage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dibenzyl trisulphide capsulesAlso: Guineahen Weed capsules20 mg once daily for 6 months | Drug | Breast Cancer Stage IV |
| Dibenzyl trisulphide capsulesAlso: Guineahen Weed capsules20 mg once daily for 6 months | Drug | Colon Cancer Stage IV |
| Dibenzyl trisulphide capsulesAlso: Guineahen Weed capsules20 mg once daily for 6 months | Drug | Cervical Cancer Stage IV |
| Dibenzyl trisulphide capsulesAlso: Guineahen Weed capsules20 mg once daily for 6 months | Drug | Cancer of the Prostate Stage IV |
| Stage IV Breast Cancer PlaceboAlso: Placebo20 mg once daily for 6 months | Drug | Breast Cancer Stage IV |
| Stage IV: Colon Cancer PlaceboAlso: Placebo20 mg once daily for 6 months | Drug | Colon Cancer Stage IV |
| Cervical Cancer Stage IV PlaceboAlso: Placebo20 mg once daily for 6 months | Drug | Cervical Cancer Stage IV |
| Cancer of the Prostate PlaceboAlso: Placebo20 mg once daily for 6 months | Drug | Cancer of the Prostate Stage IV |
Primary outcome
Prostate Cancer
Time frame: Every 8 weeks up to 52 weeks
50% change in the Prostate Specific Antigen Response (PSA)
Breast Cancer
Time frame: Every 8 weeks up to 52 weeks
Changes in size of the metastatic legions
Colon Cancer
Time frame: Every 8 weeks up to 52 weeks
50% change in the Carcinoembryonic Antigen (CEA)
Cervical Cancer
Time frame: Every 8 weeks up to 52 weeks
50% change in renal function (Renal output)
22 secondary outcomes
Haemoglobin Red Cell Test
Time frame: Every 8 weeks upto 52 weeks
Blood Platelets Tests
Time frame: Every 8 weeks upto 52 weeks
Blood urea Tests
Time frame: Every 8 weeks upto 52 weeks
Blood Creatinine
Time frame: Every 8 weeks upto 52 weeks
Blood Electrolytes
Time frame: Every 8 weeks upto 52 weeks
Blood Calcium
Time frame: Every 8 weeks upto 52 weeks
Blood Phosphorus
Time frame: Every 8 weeks upto 52 weeks
Prothrombin Test
Time frame: Every 8 weeks upto 52 weeks
Partial Prothrombin Test
Time frame: Every 8 weeks upto 52 weeks
White Blood Cell Test
Time frame: every 8 weeks up to 52 weeks
Computed Tomography (CT) Scan
Time frame: Every 8 weeks up to 52 weeks
Nuclear bone scintigraphy
Time frame: every 8 weeks up to 52 weeks
Bilirubin Direct test
Time frame: Every 8 weeks up to 52 weeks
Bilirubin Indirect test
Time frame: Every 8 weeks up to 52 weeks
Alkaline Phosphate level test (ALP)
Time frame: Every 8 weeks up to 52 weeks
Aspartate Aminotransferase test
Time frame: Every 8 weeks up to 52 weeks
Gamma-glutamyl transferase test
Time frame: Every 8 weeks up to 52 weeks
Lactate dehydrogenase test
Time frame: Every 8 weeks up to 52 weeks
Respiration
Time frame: Every 8 weeks up to 52 weeks
Temperature measurement
Time frame: Every 8 weeks up to 52 weeks
Pulse
Time frame: Every 8 weeks up to 52 weeks
Cancer Survival Curves
Time frame: Every 8 weeks up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Related trials for Stage IV Prostate Cancer
RecruitingPhase 2
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingObservational study
Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAD Williams principal investigator
University of the West Indies, Mona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dibenzyl trisulphide capsules in people with Stage IV Prostate Cancer and Stage IV Colon Cancer, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Horace Fletcher, MBBS/DM (876 927 1145, horace.fletcher@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer (time frame: Every 8 weeks up to 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.