CClinicalTrials.gg
CompletedNCT03292822Updated Jun 20, 2024

Effects of (Licochalcone A) and Paclitaxel on Human Oral Squamous Cell Carcinoma Cell Line

A Phase 1 interventional study of Licochalcone A and Paclitaxel in Squamous Cell Carcinoma, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Cairo University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the detailed description

Oral squamous cell carcinoma (OSCC) is considered the most common human body malignant tumor. It has poor prognosis regarding its distant lymph node metastasis and local destruction which lead to low survival rate.

Paclitaxel is a chemotherapeutic drug of the taxols group that is used in the treatment of lung, ovarian and prostate cancer. It is also used to treat breast, head and neck cancer as well as sarcoma and leukemia. Recent studies and researches explored that Paclitaxel has an important role in mitotic arrest activation and induction, which subsequently lead to cell death.

The conventional treatment strategies such as surgery, radiotherapy and chemotherapy come with low levels of expectations regarding prognosis and survival rate. On the other hand, serious side effects of chemotherapy such as renal toxicity, gastrointestinal upset and bone marrow suppression remain hazards which cannot be avoided.Thus, there is a great need to discover new agents and strategies for treating OSCC or even enhancing the effect of chemotherapy in order to reduce the dose given.

Licorice extract, Licochalcone A, is one of many natural extracts of Glycyrrhiza inflata plant. It has been used in treatment of inflammation, infections and cancer.

02

Conditions studied

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. All head and neck squamous cell carcinoma cell lines
  2. Licochalcone extracts
  3. Taxols group of chemotherapy

Exclusion criteria

Exclusion Criteria:

  1. Animal experimental studies
  2. Any cancer cell line other than squamous cell carcinoma cell lines.
  3. Any chemotherapeutics other than Taxols group.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Licochalcone A

    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

  • Active comparator
    Paclitaxel

    chemotherapeutic drug

    Drug: Paclitaxel

Interventions

  • Dietary supplementLicochalcone A

    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.

  • DrugPaclitaxel

    chemotherapeutic drug

    Also known as: taxol

05

What researchers measure

Primary outcomes

  1. Apoptosis

    programmed cell death

    Time frame: 3 days

06

Study locations

1 site
  • Cairo University
    Cairo, Egypt
07

References and documents

Publications

  • 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. PubMed 25572524 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 22, 2017

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03292822
Lead sponsor
Cairo University
Responsible party
Moahmed Osama mostafa (teaching assistant, Cairo University) — Principal investigator
First posted
Sep 26, 2017
Start date
Feb 15, 2021
Primary completion
Jan 1, 2023
Completion
Dec 1, 2023
Last update
Jun 20, 2024

Study contacts

Ahmed H El-Khadem, Phd
study chair · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion