NCT02076672

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
5.7 years until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

February 24, 2014

Last Update Submit

July 12, 2021

Conditions

Asbestos Exposure

Keywords

preventionnon-malignant asbestos-related diseasebenign pleural diseaseasbestosis

Outcome Measures

Primary Outcomes (1)

  • Efficacy outcome

    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.

    90 days post last subject recruitment

Secondary Outcomes (1)

  • Safety outcome

    Day 45 and Day 90

Study Arms (1)

Artichoke WPC

EXPERIMENTAL

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.

Drug: Artichoke WPC

Interventions

Artichoke WPCDRUG

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital, Firestone Institute

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

  • Muti P, Sacconi A, Pulito C, Orlandi G, Donzelli S, Morrone A, Jiulian J, Cox GP, Kolb M, Pond G, Kavsak P, Levine MN, Blandino G, Strano S. Artichoke phytocomplex modulates serum microRNAs in patients exposed to asbestos: a first step of a phase II clinical trial. J Exp Clin Cancer Res. 2022 Aug 20;41(1):255. doi: 10.1186/s13046-022-02455-6.

    PMID: 35987988DERIVED

MeSH Terms

Conditions

Asbestosis

Condition Hierarchy (Ancestors)

PneumoconiosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryOccupational Diseases

Study Officials

  • Paola Muti

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 3, 2014

Study Start

November 5, 2019

Primary Completion

April 28, 2020

Study Completion

April 28, 2020

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

CA(1)