Clinical trial NCT02076672: Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population
Official title: Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asbestos Exposure
Keywords: prevention
non-malignant asbestos-related disease
benign pleural disease
asbestosis
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Aboca Spa Societa' Agricola
First posted: 2014-03-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Efficacy outcome
timeFrame: 90 days post last subject recruitment
Secondary outcomes:
measure: Safety outcome
timeFrame: Day 45 and Day 90
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Hospital, Firestone Institute
state: Ontario
Study officials:
affiliation: McMaster University
name: Paola Muti
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.