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A Randomized, Double-blind, Single-center Clinical Trial of Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma
Oral squamous cell carcinoma is the most common malignant tumor of the oral and maxillofacial region. Currently, surgery is the main method of comprehensive treatment. TPF (paclitaxel, cisplatin, and fluorouracil) chemotherapy regimen is one of the important methods for the treatment of oral squamous cell carcinoma. Adjuvant chemotherapy before and after surgery can significantly improve the therapeutic effect of oral cancer patients. Oral mucositis (OM) is a common side effect during chemotherapy, which seriously affects the quality of life of chemotherapy patients and may lead to the termination of chemotherapy. Prevention and treatment of oral mucositis is still an urgent clinical problem. Investigators' previous studies have found that vitamin D can significantly inhibit the proliferation, migration, invasion and metastasis of oral squamous cell carcinoma cells, and vitamin D can protect normal oral mucosal tissue by inhibiting pyroptosis caused by platinum-based chemotherapy drugs. Based on the previous basic research, this project intends to conduct a single-center, prospective, clinical randomized controlled study on the clinical efficacy of vitamin D in reducing oral mucosal inflammation in patients with oral squamous cell carcinoma undergoing TPF chemotherapy, in order to provide evidence-based medical evidence for the clinical use of vitamin D in reducing oral mucosal inflammation in patients with oral cancer chemotherapy. The results of this study are expected to serve as guidelines to guide clinical practice.
Age
20 - 70 years
Sex
ALL
Healthy Volunteers
No
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Start Date
June 14, 2021
Primary Completion Date
April 30, 2024
Completion Date
April 30, 2024
Last Updated
August 29, 2023
412
ESTIMATED participants
Alfacalcidol Oral Solution
DRUG
Placebo
DRUG
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT05853692
NCT07371611
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07343271