Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (ABOCA1)
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ClinicalTrials.gov Identifier: NCT02076672 |
Recruitment Status :
Completed
First Posted : March 3, 2014
Last Update Posted : July 13, 2021
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Condition or disease | Intervention/treatment | Phase |
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Asbestos Exposure | Drug: Artichoke WPC | Phase 2 |
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 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 |
Arm | Intervention/treatment |
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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.
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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. |
- 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.
- 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.

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

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
Canada, Ontario | |
St. Joseph's Hospital, Firestone Institute | |
Hamilton, Ontario, Canada, L8N 4A6 |
Principal Investigator: | Paola Muti | McMaster University |
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: | 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 |
prevention non-malignant asbestos-related disease benign pleural disease asbestosis |