NCT02340845

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

September 18, 2014

Last Update Submit

January 13, 2015

Conditions

Cancer

Keywords

breast,colon, ovary, uterus, cervix, lungTreatments

Outcome Measures

Primary Outcomes (1)

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

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

    24 weeks

Secondary Outcomes (1)

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

    24 weeks

Other Outcomes (1)

  • Using NCI standard to measure serious and non-serious outcomes in toxicity in various types of cancer patients

    24 weeks

Study Arms (2)

Bromalian 10 mg/kg/day

ACTIVE COMPARATOR

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.

Biological: Bromelain and Comosain

Bromalian 50mg/kg/day

ACTIVE COMPARATOR

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.

Biological: Bromelain and Comosain

Interventions

Bromelain and ComosainBIOLOGICAL

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

Also known as: Ananase, Comosalin, Bromelainase, Formosain, Formosalin
Bromalian 10 mg/kg/dayBromalian 50mg/kg/day

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 - 15. All measurable tumors that have spread to the bones, liver, lung, kidney, and abdomen will be included in the data analysis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OeyamaMoto Cancer Research Foundation

West Covina, California, 91791, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Bromelainscomosain

Intervention Hierarchy (Ancestors)

Cysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidases

Study Officials

  • Benedict Liao, M.D.

    OeyamaMoto Cancer research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedict Liao, M.D.

CONTACT

6265733200kingliao1@yahoo.com

Masao Wada, M.D.

CONTACT

6265733200info@cancertreatmentus.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

January 19, 2015

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

US(1)