Clinical trial · Interventional
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)
NCT02076672CI-TRIAL-00052656ABOCA1completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asbestos Exposure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artichoke WPC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Artichoke WPC
- description
- 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.
- interventionNames
- Drug: Artichoke WPC
Primary outcomes (1)
- measure
- Efficacy outcome
- timeFrame
- 90 days post last subject recruitment
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMuti 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 35987988