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

NCT06016400 | Unknown Phase 2

• 1 other identifier: 2021-KY-049
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Squamous Cell Carcinoma; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Grading of oral mucositis in patients treated with vitamin D and placebo

  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

  Within two months from the start of chemotherapy

• Healing time of oral mucositis in vitamin D treatment group and placebo group

  Within two months from the end of chemotherapy

• Length of hospital stay of patients in vitamin D treatment group and placebo group

  Within two months from the start of chemotherapy

Study Arms (2)

intervention group

EXPERIMENTAL

Alfacalcidol Drops,1ug a day,40day

Drug: Alfacalcidol Oral Solution

control group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Alfacalcidol Oral Solution DRUG

Alfacalcidol Oral Solution 1ug a day

intervention group

Placebo DRUG

Placebo

control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Stomatitis

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 29, 2023
• Study Start: June 14, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)