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

• ClinicalTrials.gov Identifier: NCT02076672
• Recruitment Status: Completed
• First Posted: March 3, 2014
• Last Update Posted: July 13, 2021
• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Aboca Spa Societa' Agricola
• Information provided by (Responsible Party): Ontario Clinical Oncology Group (OCOG)

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 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
• Actual Primary Completion Date: April 28, 2020
• Actual Study Completion Date: April 28, 2020

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Canada, Ontario

St. Joseph's Hospital, Firestone Institute

Hamilton, Ontario, Canada, L8N 4A6

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Aboca Spa Societa' Agricola

Investigators

• Principal Investigator: Paola Muti; McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ontario Clinical Oncology Group (OCOG)
• ClinicalTrials.gov Identifier: NCT02076672
• Other Study ID Numbers: OCOG-2013-ABOCA1
• First Posted: March 3, 2014
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

• 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