Using Vitamin D to reduce inflammation in chemotherapy patients with oral cancer
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
This study is testing if a form of vitamin D can help reduce inflammation and improve the comfort of patients with oral cancer who are receiving chemotherapy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 412 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06016400 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of alfacalcidol, a form of vitamin D, to alleviate oral mucositis in patients undergoing TPF chemotherapy for oral squamous cell carcinoma. The study aims to determine if vitamin D can protect oral mucosal tissue and improve the quality of life for these patients by reducing inflammation and side effects associated with chemotherapy. Participants will be randomly assigned to receive either the vitamin D treatment or a placebo, and their progress will be monitored throughout the chemotherapy regimen.
Who should consider this trial
Good fit: Ideal candidates are patients aged 20-70 with pathologically diagnosed oral squamous cell carcinoma requiring TPF chemotherapy and who have low to adequate vitamin D levels.
Not a fit: Patients with existing oral mucosal diseases or severe systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for chemotherapy patients by reducing painful oral mucositis.
How similar studies have performed: Previous studies have indicated that vitamin D may have protective effects against oral squamous cell carcinoma, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.