- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076672
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (ABOCA1)
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)
Study Overview
Detailed Description
In individuals exposed to asbestos and affected with asbestosis or asbestos-related benign pleural disease, and therefore at increased risk of mesothelioma, the investigators will evaluate whether the treatment with the commercially-available Artichoke Whole Phytocomplex Concentrate (Artichoke WPC) for 90 days will decrease mesothelin serum levels.
Although the investigators have general information on toxicity in humans, the investigators will monitor and assess the potential toxicity of Artichoke WPC in this patient population.
In addition to mesothelin, the investigators plan to evaluate the effects of Artichoke WPC on serum microRNAs (miRNAs). The use of miRNAs as minimally-invasive biomarkers has opened new opportunities for the diagnosis of cancer. A number of studies have addressed the potential association of disregulated miRNA profiling and benign asbestos-related disease and mesothelioma. Thus, the investigators will evaluate serum miRNA profiling before and after treatment with Artichoke WPC.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Hospital, Firestone Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Asbestosis (defined as diffuse lung scarring based on increased profusion of interstitial fibrosis)
- Benign pleural disease (defined as thickening or fibrotic plaques on pleural surfaces of the lung bilaterally)
Exclusion Criteria:
- Prior systemic chemotherapy, radiation therapy or both.
- A current or previous history of primary malignancy.
- Known allergy to artichoke.
- Known bile duct obstruction.
- Known pregnancy or lactating women.
- Known psychiatric illness/social situations that would limit study compliance.
- Receiving any other investigational agents.
- Inability to understand or unable to provide written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artichoke WPC
Artichoke WPC 500 mg capsules.
Dose = 1000 mg (2 - 500 mg capsules) just before breakfast and 1000 mg (2 - 500 mg capsules) before dinner.
Duration: daily for a period of 90 days.
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Artichoke WPC 500 mg capsules.
Dose = 1000 mg (2 - 500 mg capsules) just before breakfast and 1000 mg (2 - 500 mg capsules) before dinner.
Duration: daily for a period of 90 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy outcome
Time Frame: 90 days post last subject recruitment
|
The primary efficacy outcome is based on the reduction in serum concentration levels of mesothelin, measured at baseline and at the end of the intervention for subjects in the efficacy sub-cohort (i.e. for subjects who had elevated mesothelin levels at baseline).
A positive outcome will be declared if the biomarker shows a reduction of 25% or more of its baseline value over the 90-day treatment period.
For each study subject, mesothelin serum levels for both the baseline and final blood draws will be determined at the same time and in the same batch.
This will assist in minimizing the technical variability of the assessments.
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90 days post last subject recruitment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety outcome
Time Frame: Day 45 and Day 90
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At the Day 45 and Day 90 visits, adverse reactions will be reported and graded according to the NCI CTCAE Version 4.03.
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Day 45 and Day 90
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paola Muti, McMaster University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OCOG-2013-ABOCA1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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