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

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СтатусВербування

Спонсори

Ontario Clinical Oncology Group (OCOG)

Співробітники

Aboca Spa Societa' Agricola

КЛІНІЧНЕ ДОСЛІДЖЕННЯ: NCT02076672

BioSeek: nct02076672

Ключові слова

Анотація

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.

Опис

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.

Дати

Востаннє перевірено:	10/31/2019
Перший поданий:	02/23/2014
Орієнтовна реєстрація подана:	02/25/2014
Опубліковано вперше:	03/02/2014
Останнє оновлення надіслано:	02/19/2020
Останнє оновлення опубліковано:	02/20/2020
Фактична дата початку навчання:	11/04/2019
Розрахункова дата первинного завершення:	11/30/2020
Розрахункова дата завершення дослідження:	12/31/2020

Стан або захворювання

Asbestos Exposure

Втручання / лікування

Drug: Artichoke WPC

Фаза

Фаза 2

Групи рук

Рука	Втручання / лікування
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.

Критерії прийнятності

Вік, придатний для навчання	18 Years До 18 Years
Стать, яка підходить для вивчення	All
Приймає здорових добровольців	Так
Критерії	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.

Результат

Заходи первинного результату

1. Efficacy outcome [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.

Заходи вторинного результату

1. Safety outcome [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.

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

Ключові слова

злоякісна пухлина

mesothelioma

азбестоз

артишок

артишок іспанський

протипухлинні препарати