From the blog

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (ABOCA1)

Published: November 19, 2014


Primary Outcome Measure:

  • Efficacy outcome [ Time Frame: 90 days post last subject recruitment ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:

  • Safety outcome [ Time Frame: Day 45 and Day 90 ] [ Designated as safety issue: Yes ]
    At the Day 45 and Day 90 visits, adverse reactions will be reported and graded according to the NCI CTCAE Version 4.03.

Eligibility Criteria

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.
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