Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (ABOCA1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02076672
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Aboca Spa Societa' Agricola
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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.

Condition or disease Intervention/treatment Phase
Asbestos Exposure Drug: Artichoke WPC Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asbestos

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Efficacy outcome [ Time Frame: 90 days post last subject recruitment ]
    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.


Secondary Outcome Measures :
  1. Safety outcome [ Time Frame: Day 45 and Day 90 ]
    At the Day 45 and Day 90 visits, adverse reactions will be reported and graded according to the NCI CTCAE Version 4.03.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076672


Contacts
Layout table for location contacts
Contact: Paola Muti, MD 905-527-2299 ext 42606 muti@mcmaster.ca
Contact: Lisa Rudd-Scott, RN BScN MN 905-527-2299 ext 43793 ruddl@mcmaster.ca

Locations
Layout table for location information
Canada, Ontario
St. Joseph's Hospital, Firestone Institute Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Sarah Goodwin         
Principal Investigator: Martin Kolb         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Aboca Spa Societa' Agricola
Investigators
Layout table for investigator information
Principal Investigator: Paola Muti McMaster University
Layout table for additonal information
Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT02076672    
Other Study ID Numbers: OCOG-2013-ABOCA1
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ontario Clinical Oncology Group (OCOG):
prevention
non-malignant asbestos-related disease
benign pleural disease
asbestosis