NCT03292822

Brief Summary

Oral squamous cell carcinoma (OSCC) are considered as a one of the most malignant cancers. It has prognosis due to its distant metastasis and obvious destruction which lead to low survival rate. The conventional treatment modalities such as surgery, radiotherapy and chemotherapy are only the suitable strategies until now. Investigators cannot ignore the serious side effects of chemotherapy such as gastrointestinal upset, bone marrow suppression which cannot be overcome. For all these complications, there is a great need and demand to discover a new agents and strategies for treating OSCC. Licorice extract, especially Licochalcone A, is one of many natural extracts that have used as a traditional in treatment of inflammation, microbial infections. Regarding antitumor effect, Licochalcone A reveals interesting results in programmed cell death and apoptosis in cancer cells such as prostate, bladder, colon and gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

September 12, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
3.4 years until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

September 12, 2017

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Apoptosis

    programmed cell death

    3 days

Study Arms (2)

Licochalcone A

EXPERIMENTAL

Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties.

Dietary Supplement: Licochalcone A

Paclitaxel

ACTIVE COMPARATOR

chemotherapeutic drug

Drug: Paclitaxel

Interventions

Licochalcone ADIETARY_SUPPLEMENT

Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties in vitro.

Licochalcone A

chemotherapeutic drug

Also known as: taxol
Paclitaxel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All head and neck squamous cell carcinoma cell lines
  • Licochalcone extracts
  • Taxols group of chemotherapy

You may not qualify if:

  • Animal experimental studies
  • Any cancer cell line other than squamous cell carcinoma cell lines.
  • Any chemotherapeutics other than Taxols group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Park MR, Kim SG, Cho IA, Oh D, Kang KR, Lee SY, Moon SM, Cho SS, Yoon G, Kim CS, Oh JS, You JS, Kim DK, Seo YS, Im HJ, Kim JS. Licochalcone-A induces intrinsic and extrinsic apoptosis via ERK1/2 and p38 phosphorylation-mediated TRAIL expression in head and neck squamous carcinoma FaDu cells. Food Chem Toxicol. 2015 Mar;77:34-43. doi: 10.1016/j.fct.2014.12.013. Epub 2015 Jan 5.

    PMID: 25572524BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

licochalcone APaclitaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Ahmed H El-Khadem, Phd

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 26, 2017

Study Start

February 15, 2021

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations