Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Anti Cancer Potential of Saffron in Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464380
• Other study ID #: 1167/05/2024
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 30, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: Ain Shams University
• Contact: Amal A. Elkholy
• Phone: 01060355448
• Email: amal.elkhouly[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Saffron has recently gained considerable interest for its capacity to interfere with cancer at initiation and promotion stages as well as for cancer treatment. Although saffron and its constituents have been shown to have antitumorigenic and proapoptotic activities in different cancer cell lines. The aim of the current investigation is to identify the anti-cancer potentiality of saffron on hepatocellular carcinoma patients.

Description:

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer mortality in the world. Chronic infection with hepatitis B and C is the major risk factors for HCC worldwide. Other factors that contribute to the formation of HCC include exposure to environmental carcinogens, iron overload, fatty liver disease, and alcohol abuse. there has been a sustained rise in its incidence in both developing and developed countries. Despite the growing therapeutic options for patients with cancer, their efficacy is time-limited and non-curative. Hence to overcome these drawbacks, an incessant screening for superior and safer drugs has been ongoing for numerous decades, resulting in the detection of anti-cancer properties of several phytochemicals. Chemoprevention using readily available natural substances from vegetables, fruits, herbs and spices is one of the significantly important approaches for cancer prevention in the present era. Among the spices, saffron has generated interest because pharmacological experiments have established numerous beneficial properties including radical scavenging, anti-mutagenic and immuno-modulating effects. Saffron is a naturally derived plant product from the dried stigma of the Crocus sativus flower (family Iridaceae) that may have biologically useful properties. In fact, saffron extract and its biologically active compounds, including crocin, crocetin, carotene, and safranal, have been shown both in vitro and in vivo to possess antioxidant, anticancer, anti-inflammatory, and memory-improving properties. Saffron is also used in folk medicine as an antispasmodic, antidepressant, and aphrodisiac. Furthermore, it is one of the most commonly used species around the world for flavouring and colouring foods. Saffron has recently gained considerable interest for its capacity to interfere with cancer at initiation and promotion stages as well as for cancer treatment. Although saffron and its constituents have been shown to have antitumorigenic and proapoptotic activities in different cancer cell lines.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male and female patients above 18 years
• Patients with end-stage HCC not candidate for curative, loco regional treatment and /or systemic chemotherapy
• Patients with available baseline laboratory parameters and contrast- enhancing images after given written consent for research participation.

Exclusion Criteria:

• Patients who are candidate for curative and/or loco-regional or combination treatment for HCC
• Patients with concomitant malignancies other than HCC

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Dietary Supplement:
• Saffranal
HCC patients will receive 50 mg safranal regimen in dose of once per day for three months.
• Placebo
HCC patients will receive Placebo in dose of once per day for three months.

Locations

Country	Name	City	State
Egypt	Amal A. Elkholy	Al 'Abbasiyah	Al Abbasiya
Egypt	Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute	Cairo

Sponsors (6)

Lead Sponsor	Collaborator
Ain Shams University	Ahmed Cordie Endemic Medicine department, Cairo University Hospitals., Amr Amin Biology Department, UAE University, Al Ain 15551, UAE; Al Ain., Gamal Esmat Faculty of Biotechnology, Misr University for Science and Technology, Giza, Egypt., Mohamed, Ahmed A., M.D., Nouran Mohamed Endemic Medicine department, Cairo University Hospitals.

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Abdullaev FI, Espinosa-Aguirre JJ. Biomedical properties of saffron and its potential use in cancer therapy and chemoprevention trials. Cancer Detect Prev. 2004;28(6):426-32. doi: 10.1016/j.cdp.2004.09.002. — View Citation

Abdullaev FI. Cancer chemopreventive and tumoricidal properties of saffron (Crocus sativus L.). Exp Biol Med (Maywood). 2002 Jan;227(1):20-5. doi: 10.1177/153537020222700104. — View Citation

Bhandari PR. Crocus sativus L. (saffron) for cancer chemoprevention: A mini review. J Tradit Complement Med. 2015 Jan 28;5(2):81-7. doi: 10.1016/j.jtcme.2014.10.009. eCollection 2015 Apr. — View Citation

Das I, Das S, Saha T. Saffron suppresses oxidative stress in DMBA-induced skin carcinoma: A histopathological study. Acta Histochem. 2010 Jul;112(4):317-27. doi: 10.1016/j.acthis.2009.02.003. Epub 2009 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	overall survival in patients presented with end-stage hepatocellular carcinoma.	three months
Secondary	treatment response	response to treatment through impact on the underlying liver status	three months