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Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma

A

Ain Shams University

Status and phase

Not yet enrolling
Phase 4

Conditions

Hepatocellular Carcinoma

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Saffranal

Study type

Interventional

Funder types

Other

Identifiers

NCT06464380
1167/05/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

safranal Group
Active Comparator group
Description:
include 20 HCC patients will receive 50 mg safranal regimen in dose of once per day for six months.
Treatment:
Dietary Supplement: Saffranal
Control Group
Placebo Comparator group
Description:
include 20 HCC patients will receive placebo in the form of once per day for six months.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Central trial contact

Amal A. Elkholy

Data sourced from clinicaltrials.gov

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