Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether vitamin D can help reduce inflammation in the mouth for patients with oral squamous cell carcinoma who are undergoing chemotherapy. Oral squamous cell carcinoma is a type of cancer that affects the mouth, and chemotherapy can lead to painful mouth sores, known as oral mucositis, which can make treatment difficult and affect a patient’s quality of life. The researchers hope to find out if vitamin D can lessen these side effects and improve the overall experience for patients undergoing treatment.

To participate in this study, patients must be between 20 and 70 years old and have been diagnosed with oral squamous cell carcinoma. They also need to be starting a specific chemotherapy treatment called TPF and have low or adequate levels of vitamin D before beginning chemotherapy. Participants will be monitored during the trial to see how vitamin D impacts their mouth inflammation. It's important to note that individuals with certain health conditions or other complications are not eligible to join. Overall, this study aims to provide valuable information that could help improve treatment for future patients.

Gender

ALL

Eligibility criteria

• 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