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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis; Oral Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Placebo; Drug: Alfacalcidol Oral Solution

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: zhiquan huang, PH.D; Phone Number: 13826142898; Email: hzhquan@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; Placebo	Drug: Placebo; Placebo
Experimental: intervention group; Alfacalcidol Drops,1ug a day,40day	Drug: Alfacalcidol Oral Solution; Alfacalcidol Oral Solution 1ug a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Neoplasms, Squamous Cell; Carcinoma; Inflammation; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Mucositis; Stomatitis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Alfacalcidol; Hydroxycholecalciferols
• Other Study ID Numbers: 2021-KY-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No