CompletedPhase 2

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

Canada3 participantsStarted 2019-11-05

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

Efficacy outcome

Timeframe: 90 days post last subject recruitment

Trial details

NCT IDNCT02076672

SponsorOntario Clinical Oncology Group (OCOG)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-28

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