Use of Dibenzyl Trisulphide as a Chemotherapeutic Agent in Stage Four Cancer of the Breast, Prostate, Cervix and Colon
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Prostate Cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Breast Cancer Stage IV
Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
干预措施: Dibenzyl trisulphide capsules (Drug)
Breast Cancer Stage IV
Stage IV Breast Cancer: Dibenzyl trisulphide capsules (20mg once daily)/6 months
干预措施: Stage IV Breast Cancer Placebo (Drug)
Colon Cancer Stage IV
Stage IV Colon Cancer:Dibenzyl trisulphide capsules (20 mg one daily for 6 months
干预措施: Dibenzyl trisulphide capsules (Drug)
Cervical Cancer Stage IV
Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
干预措施: Dibenzyl trisulphide capsules (Drug)
Cervical Cancer Stage IV
Stage IV Cancer of the Cervix: Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
干预措施: Cervical Cancer Stage IV Placebo (Drug)
Cancer of the Prostate Stage IV
Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
干预措施: Dibenzyl trisulphide capsules (Drug)
Cancer of the Prostate Stage IV
Stage IV Prostate cancer:Dibenzyl trisulphide capsules (20 mg once daily) for 6 months
干预措施: Cancer of the Prostate Placebo (Drug)
结局指标
主要结局
Prostate Cancer
时间窗: Every 8 weeks up to 52 weeks
50% change in the Prostate Specific Antigen Response (PSA)
Colon Cancer
时间窗: Every 8 weeks up to 52 weeks
50% change in the Carcinoembryonic Antigen (CEA)
Breast Cancer
时间窗: Every 8 weeks up to 52 weeks
Changes in size of the metastatic legions
Cervical Cancer
时间窗: Every 8 weeks up to 52 weeks
50% change in renal function (Renal output)
次要结局
- Blood urea Tests(Every 8 weeks upto 52 weeks)
- Blood Creatinine(Every 8 weeks upto 52 weeks)
- Blood Calcium(Every 8 weeks upto 52 weeks)
- Nuclear bone scintigraphy(every 8 weeks up to 52 weeks)
- Bilirubin Direct test(Every 8 weeks up to 52 weeks)
- Blood Platelets Tests(Every 8 weeks upto 52 weeks)
- Alkaline Phosphate level test (ALP)(Every 8 weeks up to 52 weeks)
- Haemoglobin Red Cell Test(Every 8 weeks upto 52 weeks)
- Blood Electrolytes(Every 8 weeks upto 52 weeks)
- Blood Phosphorus(Every 8 weeks upto 52 weeks)
- Bilirubin Indirect test(Every 8 weeks up to 52 weeks)
- Computed Tomography (CT) Scan(Every 8 weeks up to 52 weeks)
- Gamma-glutamyl transferase test(Every 8 weeks up to 52 weeks)
- Lactate dehydrogenase test(Every 8 weeks up to 52 weeks)
- Cancer Survival Curves(Every 8 weeks up to 52 weeks)
- Prothrombin Test(Every 8 weeks upto 52 weeks)
- Partial Prothrombin Test(Every 8 weeks upto 52 weeks)
- White Blood Cell Test(every 8 weeks up to 52 weeks)
- Temperature measurement(Every 8 weeks up to 52 weeks)
- Aspartate Aminotransferase test(Every 8 weeks up to 52 weeks)
- Respiration(Every 8 weeks up to 52 weeks)
- Pulse(Every 8 weeks up to 52 weeks)