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

• Status: Completed
• Trial end date: 2020-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Aboca SpA Societa Agricola; Aboca Spa Societa' Agricola

Criteria

Inclusion Criteria:

1. Asbestosis (defined as diffuse lung scarring based on increased profusion of interstitial fibrosis)

2. Benign pleural disease (defined as thickening or fibrotic plaques on pleural surfaces of the lung bilaterally)

Exclusion Criteria:

1. Prior systemic chemotherapy, radiation therapy or both.

2. A current or previous history of primary malignancy.

3. Known allergy to artichoke.

4. Known bile duct obstruction.

5. Known pregnancy or lactating women.

6. Known psychiatric illness/social situations that would limit study compliance.

7. Receiving any other investigational agents.

8. Inability to understand or unable to provide written informed consent.