Clinical trial NCT06464380: Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma
Official title: Anti Cancer Potential of Saffron in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: Saffron
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Mohamed, Ahmed A., M.D.
name: Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE.
name: Ahmed Cordie Endemic Medicine department, Cairo University Hospitals.
name: Nouran Mohamed Endemic Medicine department, Cairo University Hospitals.
name: Gamal Esmat Faculty of Biotechnology, Misr University for Science and Technology, Giza, Egypt.
First posted: 2024-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: three months
Secondary outcomes:
measure: treatment response
timeFrame: three months
Other outcomes:
Locations:
city: Al 'Abbāsīyah
country: Egypt
facility: Amal A. Elkholy
state: Al Abbasiya
city: Cairo
country: Egypt
facility: Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute
Study officials:
References:
citation: 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.
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.
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.
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.