Clinical trial NCT03292822: Effects of (Licochalcone A) and Paclitaxel on Human Oral Squamous Cell Carcinoma Cell Line
Official title: Apoptotic and Anti-Proliferative Effects of Licorice Extract (Licochalcone A) and Paclitaxel Chemotherapy on Human Oral Squamous Cell Carcinoma Cell Line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Squamous Cell Carcinoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Apoptosis
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Ahmed H El-Khadem, Phd
role: STUDY_CHAIR
References:
citation: 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.