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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
412
Alfacalcidol Oral Solution 1ug a day
Placebo
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGWithin two months from the start of chemotherapy
Oral mucosal hyperemia, erythema, erosion, ulceration and fibrosis appear, accompanied by clinical manifestations such as pain, difficulty eating, dry mouth, and taste disturbance.
Time frame: Within two months from the start of chemotherapy
Grading of oral mucositis in patients treated with vitamin D and placebo
According to the American Oncology Nurse Oral Mucositis Evaluation Scale, the score \<8 is normal; 9-10 is mild; 11-12 is moderate; \>12 is severe
Time frame: Within two months from the start of chemotherapy
Changes in the quality of life of patients in vitamin D treatment group and placebo group before
University of Washington quality of life scale
Time frame: Within two months from the start of chemotherapy
Healing time of oral mucositis in vitamin D treatment group and placebo group
Time to cure of patients with oral mucositis
Time frame: Within two months from the end of chemotherapy
Length of hospital stay of patients in vitamin D treatment group and placebo group
Length of hospital stay
Time frame: Within two months from the start of chemotherapy
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