NCT06464380

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

June 13, 2024

Last Update Submit

September 19, 2024

Conditions

Hepatocellular Carcinoma

Keywords

Saffron

Outcome Measures

Primary Outcomes (1)

  • overall survival

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

    three months

Secondary Outcomes (1)

  • treatment response

    three months

Study Arms (2)

safranal Group

ACTIVE COMPARATOR

include 20 HCC patients will receive 50 mg safranal regimen in dose of once per day for six months.

Dietary Supplement: Saffranal

Control Group

PLACEBO COMPARATOR

include 20 HCC patients will receive placebo in the form of once per day for six months.

Dietary Supplement: Placebo

Interventions

SaffranalDIETARY_SUPPLEMENT

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

safranal Group
PlaceboDIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amal A. Elkholy

Al ‘Abbāsīyah, Al Abbasiya, 123456, Egypt

Location

Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute

Cairo, 123456, Egypt

Location

Related 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.

    PMID: 15582266BACKGROUND

  • 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.

    PMID: 11788779BACKGROUND

  • 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.

    PMID: 26151016BACKGROUND

  • 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.

    PMID: 19328523BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Amal A. Elkholy

CONTACT

01060355448amal.elkhouly@pharma.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

October 30, 2024

Primary Completion

May 1, 2025

Study Completion

October 1, 2025

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations

EG(2)