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Proteolytic Enzyme
Bromalian 50mg/kg/day for Cancer
Phase 2
Waitlist Available
Led By Benedict Liao, M.D.
Research Sponsored by Oeyama-Moto Cancer Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Using NCI standard measurement to measure primary target lesion size of various types of cancer pstients
Secondary outcome measures
Using NCI standard measurement to measure non-target lesion (tumor markers) value in various types of cancer patients
Other outcome measures
Using NCI standard to measure serious and non-serious outcomes in toxicity in various types of cancer patients
Trial Design
2Treatment groups
Active Control
Group I: Bromalian 50mg/kg/dayActive Control1 Intervention
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.
Group II: Bromalian 10 mg/kg/dayActive Control1 Intervention
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.
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Who is running the clinical trial?
Oeyama-Moto Cancer Research FoundationLead Sponsor
Benedict Liao, M.D.Principal InvestigatorOeyamaMoto Cancer research Foundation
Frequently Asked Questions
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