Status:
UNKNOWN
Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Oral Squamous Cell Carcinoma
Oral Mucositis
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Patients aged 20-70 years
- Patients with pathologically diagnosed oral squamous cell carcinoma who need TPF-based chemotherapy regimens, and whose expected survival time is greater than 6 months
- Patients whose serum 25-hydroxyvitamin D level was vitamin D deficiency (\<30nmol/L) and adequate (30-50nmol/L) before chemotherapy
- Patients and their families agree to participate in this trial and sign an informed consent form
- No cognitive impairment
Exclusion
- People with oral ulcers or other oral mucosal diseases (such as: oral mucosal pemphigus, etc.) at the beginning of the study
- Patients who are allergic to alfacalcidol drops
- Patients with severe cardiac insufficiency, liver and kidney insufficiency, and systemic infectious diseases
- Pregnant women (judged by HCG test) and lactating patients
- Participating in other clinical trials during the study
- Those who do not understand or cooperate with clinical trials
- Patients with hypervitaminosis D, hypercalcemia, hyperphosphatemia and renal rickets
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT06016400
Start Date
June 14 2021
End Date
April 30 2024
Last Update
August 29 2023
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China