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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06016400

Collaborator

(none)

412

Enrollment

Location

Arms

34.5

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Oral Squamous Cell Carcinoma Oral Mucositis	Drug: Alfacalcidol Oral Solution Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

412 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 14, 2021

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intervention group

Alfacalcidol Drops,1ug a day,40day

Drug: Alfacalcidol Oral Solution

Alfacalcidol Oral Solution 1ug a day

Placebo Comparator: control group

Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Within two months from the start of chemotherapy [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.

Secondary Outcome Measures

Grading of oral mucositis in patients treated with vitamin D and placebo [Within two months from the start of chemotherapy]
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
Changes in the quality of life of patients in vitamin D treatment group and placebo group before [Within two months from the start of chemotherapy]
University of Washington quality of life scale
Healing time of oral mucositis in vitamin D treatment group and placebo group [Within two months from the end of chemotherapy]
Time to cure of patients with oral mucositis
Length of hospital stay of patients in vitamin D treatment group and placebo group [Within two months from the start of chemotherapy]
Length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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