Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population

Study Overview
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Brief Summary
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This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex extract from the artichoke plant as a chemoprevention agent.

Detailed Description
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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.

Official Title
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Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)

Conditions
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Asbestos Exposure

Intervention / Treatment
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* Drug: Artichoke WPC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artichoke WPC<br>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. | Drug: Artichoke WPC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy outcome | 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. | 90 days post last subject recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome | At the Day 45 and Day 90 visits, adverse reactions will be reported and graded according to the NCI CTCAE Version 4.03. | Day 45 and Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, non-malignant asbestos-related disease, benign pleural disease, asbestosis