Hepatocellular CarcinomaPhase 4NCT06464380
Anti-cancer Potentiality of Saffron Against Hepatocellular Carcinoma
A Phase 4 study testing Saffranal in people with Hepatocellular Carcinoma, run by Ain Shams University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Saffranal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Oct 2024to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are candidate for curative and/or loco-regional or combination treatment for HCC
- Patients with concomitant malignancies other than HCC
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Amal A. Elkholy
Al ‘Abbāsīyah, Al Abbasiya, 123456
Amal A. Elkholy, 01060355448, amal.elkhouly@pharma.asu.edu.eg
Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute
Cairo, 123456
About this study
Official title: Anti Cancer Potential of Saffron in 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Saffranal, Placebo
- Keywords
- Saffron
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaffranalDietary supplement
HCC patients will receive 50 mg safranal regimen in dose of once per day for six months.
PlaceboDietary supplement
HCC patients will receive Placebo in dose of once per day for six months.
| Study group | Role | What they receive |
|---|---|---|
| safranal Group | Active comparator | include 20 HCC patients will receive 50 mg safranal regimen in dose of once per day for six months. Receives: Dietary Supplement: Saffranal |
| Control Group | Placebo comparator | include 20 HCC patients will receive placebo in the form of once per day for six months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival in patients presented with end-stage hepatocellular carcinoma.
Measured: three months
Secondary outcomes (1)
treatment response
response to treatment through impact on the underlying liver status
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start30 Oct 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE., Ahmed Cordie Endemic Medicine department, Cairo University Hospitals., Nouran Mohamed Endemic Medicine department, Cairo University Hospitals., Misr University for Science and Technology
- Responsible party
- Principal investigator, Amal A. Elkholy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464380
- Sponsor's protocol ID
- 1167/05/2024
- Status last verified
- Sep 2024
- First submitted
- 13 Jun 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15582266Abdullaev 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.
PubMed 11788779Bhandari 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.
PubMed 26151016Das 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.
PubMed 19328523
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Cancer Potential of Saffron in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06464380
- Acronym / sponsor ID
- 1167/05/2024
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Saffron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Amr Amin College of Medicine, University of Sharjah, Sharjah 27272, UAE., Ahmed Cordie Endemic Medicine department, Cairo University Hospitals., Nouran Mohamed Endemic Medicine department, Cairo University Hospitals., Misr University for Science and Technology
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| safranal Group | Active comparator | Dietary Supplement: Saffranalinclude 20 HCC patients will receive 50 mg safranal regimen in dose of once per day for six months. |
| Control Group | Placebo comparator | Dietary Supplement: Placeboinclude 20 HCC patients will receive placebo in the form of once per day for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are candidate for curative and/or loco-regional or combination treatment for HCC
- Patients with concomitant malignancies other than HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaffranalHCC patients will receive 50 mg safranal regimen in dose of once per day for six months. | Dietary supplement | safranal Group |
| PlaceboHCC patients will receive Placebo in dose of once per day for six months. | Dietary supplement | Control Group |
Primary outcome
overall survival
Time frame: three months
overall survival in patients presented with end-stage hepatocellular carcinoma.
1 secondary outcome
treatment response
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 15582266Abdullaev 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.
- Background: PubMed 11788779Abdullaev 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.
- Background: PubMed 26151016Bhandari 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.
- Background: PubMed 19328523Das 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saffranal in people with Hepatocellular Carcinoma, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal A. Elkholy (01060355448, amal.elkhouly@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464380, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.