Oral Mucositis, Oral Squamous Cell Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGAlfacalcidol Oral Solution
Alfacalcidol Oral Solution 1ug a day
DRUGPlacebo
Placebo
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 20-70 years 2. Patients with pathologically diagnosed oral squamous cell carcinoma who need TPF-based chemotherapy regimens, and whose expected survival time is greater than 6 months 3. Patients whose serum 25-hydroxyvitamin D level was vitamin D deficiency (\<30nmol/L) and adequate (30-50nmol/L) before chemotherapy 4. Patients and their families agree to participate in this trial and sign an informed consent form 5. No cognitive impairment
Exclusion criteria
1. People with oral ulcers or other oral mucosal diseases (such as: oral mucosal pemphigus, etc.) at the beginning of the study 2. Patients who are allergic to alfacalcidol drops 3. Patients with severe cardiac insufficiency, liver and kidney insufficiency, and systemic infectious diseases 4. Pregnant women (judged by HCG test) and lactating patients 5. Participating in other clinical trials during the study 6. Those who do not understand or cooperate with clinical trials 7. Patients with hypervitaminosis D, hypercalcemia, hyperphosphatemia and renal rickets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within two months from the start of chemotherapy | Within 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grading of oral mucositis in patients treated with vitamin D and placebo | Within two months from the start of chemotherapy | 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 |
| Changes in the quality of life of patients in vitamin D treatment group and placebo group before | Within two months from the start of chemotherapy | University of Washington quality of life scale |
| Healing time of oral mucositis in vitamin D treatment group and placebo group | Within two months from the end of chemotherapy | Time to cure of patients with oral mucositis |
| Length of hospital stay of patients in vitamin D treatment group and placebo group | Within two months from the start of chemotherapy | Length of hospital stay |
Countries
China
Outcome results
None listed