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

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016400
• Other study ID #: 2021-KY-049
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 14, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 412
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Inflammation
• Mucositis
• Oral Mucositis
• Oral Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Stomatitis

Intervention

Drug:
• Alfacalcidol Oral Solution
Alfacalcidol Oral Solution 1ug a day
• Placebo
Placebo

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within two months from the start of chemotherapy
Secondary	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	Within two months from the start of chemotherapy
Secondary	Changes in the quality of life of patients in vitamin D treatment group and placebo group before	University of Washington quality of life scale	Within two months from the start of chemotherapy
Secondary	Healing time of oral mucositis in vitamin D treatment group and placebo group	Time to cure of patients with oral mucositis	Within two months from the end of chemotherapy
Secondary	Length of hospital stay of patients in vitamin D treatment group and placebo group	Length of hospital stay	Within two months from the start of chemotherapy