Recruiting
Phase 2

Bromelain

Sponsor:

Oeyama-Moto Cancer Research Foundation

Code:

NCT02340845

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bromelain and Comosain

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT02340845

Start date

May, 2014

Status verified date

Jan, 2015

Completion date

Feb, 2015

Anticipated

Primary completion date

Jan, 2015

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bromalian 10 mg/kg/day

The number of patients suffering from well-documented malignancies to be assigned to this group will be at least 30: with mixed types of carcinoma of breast, lung, colon, gastro-intestinal, ovarian, cervical, uterine, prostatic, bladder, hepatic, lymphoma, melanoma and so forth. These patients will be given Bromelain at 500 mg/day, divided into two doses of 250 mg/dose and taken with meals.

active comparator: Bromalian 50mg/kg/day

The number of patients suffering from well-documented malignancies with be at least 60: with mixed types of carcinoma of breast, lung, colon, gastro-intestinal, ovarian, cervical, uterine, prostatic, bladder, hepatic, lymphoma, melanoma and so forth. These patients will be given Bromelain at 2400 mg/day, divided into two doses of 1200 mg/dose and taken with meals.

Interventions

Bromelain and Comosain

Treatment of solid tumors in advanced stage of lung, breast, colon, ovary, cervix, uterus, prostatic, and liver

Primary outcome measure

  • Using NCI standard measurement to measure primary target lesion size of various types of cancer pstients [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

OeyamaMoto Cancer Research Foundation

Recruiting

West Covina, California, United States, 91791

Contacts

More Information

Sponsor

Oeyama-Moto Cancer Research Foundation

Last update posted

Jan 19, 2015

Last verified

Jan, 2015

Keywords

  • breast,colon, ovary, uterus, cervix, lung
  • Treatments

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oeyama-Moto Cancer Research Foundation on 2015-01-19.