Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
Son Doğrulandı: | 10/31/2019 |
İlk Gönderilen: | 02/23/2014 |
Tahmini Kayıt Gönderildi: | 02/25/2014 |
İlk Gönderilen: | 03/02/2014 |
Son Güncelleme Gönderildi: | 02/19/2020 |
Son Güncelleme Gönderildi: | 02/20/2020 |
Fiili Çalışma Başlangıç Tarihi: | 11/04/2019 |
Tahmini Birincil Tamamlanma Tarihi: | 11/30/2020 |
Tahmini Çalışma Tamamlanma Tarihi: | 12/31/2020 |
Durum veya hastalık
Müdahale / tedavi
Drug: Artichoke WPC
Evre
Kol Grupları
Kol | Müdahale / tedavi |
---|---|
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. |
Uygunluk kriterleri
Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
Çalışmaya Uygun Cinsiyetler | All |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
Kriterler | 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. |
Sonuç
Birincil Sonuç Ölçütleri
1. Efficacy outcome [90 days post last subject recruitment]
İkincil Sonuç Ölçütleri
1. Safety outcome [Day 45 and Day 90]