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

NCT02076672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-07-13

No results posted yet for this study

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.

Conditions

  • Asbestos Exposure

Interventions

DRUG

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.

Sponsors & Collaborators

  • Aboca Spa Societa' Agricola

    collaborator INDUSTRY

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Paola Muti · McMaster University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2020-04-28
Completion
2020-04-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02076672 on ClinicalTrials.gov