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临床试验/NCT02340845
NCT02340845Unknown2 期

The Methods and Compositions for Treating / Preventing Various Types of Cancer Which Comprise Administered an Effective Amount of Glyco-Polypeptides, Such as Comosain, Bromelainases, Ananase, and a Mixture Thereof. By Way of (a) MMAPKinase (Major Mitogen Activiting Protein Kinase), (b) TPKinase (Tryosine Phosphorylation Kinase) Inhibitors Which Induce Cascade Production of Interleukin II B, 6, 8 & TNFs Through TCRs/ CD-2, TCRs/ CD-3 of WBC

Oeyama-Moto Cancer Research Foundation2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
100
试验地点
2
主要终点
Using NCI standard measurement to measure primary target lesion size of various types of cancer pstients

研究概览

简要总结

The Phase II randomized, two-armed clinical study will investigate the efficacy of high dose versus low dose Bromelain (Comosain) in human subjects diagnosed with advanced late stage cancers. The study subjects will be randomly assigned to each group by a coin toss. Bromelain (Comosain) extract, derived from the stem and fruit of Ananas Comosus will be administered orally each day.

详细描述

  1. Patient Eligibility and Selection

Patients suffering from late stage breast, lung, colon, cervical, ovarian, and uterine cancers in stages III and IV, with tissue proof of well-documented malignancies, whether by tissue biopsies and/or laparatomy or thoracotomy and have not been helped by conventional radiation therapy and/or chemotherapies are eligible for this study. Additionally the following conditions must be met:

  1. Patient's age is between 18 and 85 years.
  2. Patient is not taking anticoagulants or on antiplatelet therapy.
  3. Patient does not have a history of abdominal fistula, gastroenteral perforation, peptic ulcer diseases, or intra-abdominal abscess within 6 months prior to study enrollment.
  4. Patient has not had major surgery within 4 weeks prior to study enrollment. Patients who have not recovered from adverse events due to surgery performed more than 4 weeks earlier are not eligible for this study.
  5. Patient does not currently have uncontrolled hypertension, diabetes, or clinically significant cardiac arrhythmia.
  6. Patient does not have an allergic reaction to Bromelain or pineapple-containing products.
  7. Female patients should not be pregnant or breastfeeding.
  8. Patient's platelet counts must be greater than 100,000/mL.
  9. Patient's hemoglobin must be greater than 9.0 g/dL.
  10. Patient does not have significant abnormal hepatic and/or renal function.
  11. Patient's tumors are measurable; between 0.2 - 10 cm in size and number between 1 - 15. All measurable tumors that have spread to the bones, liver, lung, kidney, and abdomen will be included in the data analysis.

Patients with following conditions will be excluded from the study:

  1. Hemoglobulin less than 9 g/dL and WBC less than 4.0 k/µL.
  2. Platelet count less than 100,000/µL.
  3. INR greater than 1.5
  4. Patient currently taking therapeutic doses of warfarin or anti anti-platelet agents.
  5. Patient has a history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.
  6. Patient currently has uncontrolled hypertension, diabetes, or clinically significant cardiac arrhythmia.
  7. Patient who had major surgery performed within 4 weeks prior to entering the study; and patients who have not recovered from adverse events due to surgery performed more than 4 weeks earlier.
  8. Patient with a history of allergic reaction to Bromelain or pineapple-containing products.
  9. Female patients who are pregnant or breastfeeding.
  10. Patient with tumors that are widely spread in the chest and abdomen that cannot be measured by CT scan.

Patients who are eligible for this study will be randomly assigned to either the low dose group or the high dose group by a coin toss. Each study subject will be assigned a patient number for the purpose of this study. 2. Drug Dosage and Schedule

High Dose Group-The oral dose of Bromelain (50 mg/kg/day) is extrapolated from in vivo animal studies, and determined to be safe by a Safety study on healthy human subjects (see Section VII-A). For this clinical investigation, the High Dose group will be given Bromelain at 50 mg/kg/day, to a maximum of 2400 mg/day (divided into 2 doses/day of 1200 mg/dose)

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from late stage breast, lung, colon, cervical, ovarian, and uterine cancers in stages III and IV, with tissue proof of well-documented malignancies, whether by tissue biopsies and/or laparatomy or thoracotomy and have not been helped by conventional radiation therapy and/or chemotherapies are eligible for this study. Additionally the following conditions must be met:
  • Patient's age is between 18 and 85 years.
  • Patient is not taking anticoagulants or on antiplatelet therapy.
  • Patient does not have a history of abdominal fistula, gastroenteral perforation, peptic ulcer diseases, or intra-abdominal abscess within 6 months prior to study enrollment.
  • Patient has not had major surgery within 4 weeks prior to study enrollment. Patients who have not recovered from adverse events due to surgery performed more than 4 weeks earlier are not eligible for this study.
  • Patient does not currently have uncontrolled hypertension, diabetes, or clinically significant cardiac arrhythmia.
  • Patient does not have an allergic reaction to Bromelain or pineapple-containing products.
  • Female patients should not be pregnant or breastfeeding.
  • Patient's platelet counts must be greater than 100,000/mL.
  • Patient's hemoglobin must be greater than 9.0 g/dL.
  • Patient does not have significant abnormal hepatic and/or renal function.
  • Patient's tumors are measurable; between 0.2 - 10 cm in size and number between 1 -
  • All measurable tumors that have spread to the bones, liver, lung, kidney, and abdomen will be included in the data analysis.

排除标准

  • Patients with following conditions will be excluded from the study:
  • Hemoglobulin less than 9 g/dL and WBC less than 4.0 k/µL.
  • Platelet count less than 100,000/µL.
  • INR greater than 1.5
  • Patient currently taking therapeutic doses of warfarin or anti anti-platelet agents.
  • Patient has a history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.
  • Patient currently has uncontrolled hypertension, diabetes, or clinically significant cardiac arrhythmia.
  • Patient who had major surgery performed within 4 weeks prior to entering the study; and patients who have not recovered from adverse events due to surgery performed more than 4 weeks earlier.
  • Patient with a history of allergic reaction to Bromelain or pineapple-containing products.
  • Female patients who are pregnant or breastfeeding.
  • Patient with tumors that are widely spread in the chest and abdomen that cannot be measured by CT scan.
  • Patients who are eligible for this study will be randomly assigned to either the low dose group or the high dose group by a coin toss. Each study subject will be assigned a patient number for the purpose of this study.

结局指标

主要结局

Using NCI standard measurement to measure primary target lesion size of various types of cancer pstients

时间窗: 24 weeks

Measurement of the size of tumor lesion in centimeters and shrinking of regional lymphnodes

次要结局

  • Using NCI standard measurement to measure non-target lesion (tumor markers) value in various types of cancer patients(24 weeks)

研究者

发起方
Oeyama-Moto Cancer Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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