Title
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)
Phase
Phase 2Lead Sponsor
McMaster UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Asbestos ExposureIntervention/Treatment
artichoke ...Study Participants
3This 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.
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.
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.
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.
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.
