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NCT Number: NCT06464380

Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amal A. Elkholy, Al ‘Abbāsīyah, Al Abbasiya, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saffranal

Dietary Supplement

HCC patients will receive 50 mg safranal regimen in dose of once per day for six months.

Placebo

Dietary Supplement

HCC patients will receive Placebo in dose of once per day for six months.

Primary outcomes

  1. overall survival

    Time frame: three months

    overall survival in patients presented with end-stage hepatocellular carcinoma.

Secondary outcomes

  1. treatment response

    Time frame: three months

    response to treatment through impact on the underlying liver status

Study contacts

Contact information is provided by the study sponsor or research team.

Amal A. Elkholy

CONTACT

[email protected]

01060355448

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Ahmed Cordie Endemic Medicine department, Cairo University Hospitals.
  • Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE.
  • Misr University for Science and Technology
  • Mohamed, Ahmed A., M.D.
  • Nouran Mohamed Endemic Medicine department, Cairo University Hospitals.

Registry information

Official study title

Anti Cancer Potential of Saffron in Hepatocellular Carcinoma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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