search
Back to results

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

Primary Purpose

Oral Squamous Cell Carcinoma, Oral Mucositis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Alfacalcidol Oral Solution
Placebo
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Squamous Cell Carcinoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sun Yat-sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention group

control group

Arm Description

Alfacalcidol Drops,1ug a day,40day

Placebo

Outcomes

Primary Outcome Measures

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
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
University of Washington quality of life scale
Healing time of oral mucositis in vitamin D treatment group and placebo group
Time to cure of patients with oral mucositis
Length of hospital stay of patients in vitamin D treatment group and placebo group
Length of hospital stay

Full Information

First Posted
August 7, 2023
Last Updated
August 24, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT06016400
Brief Title
Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Squamous Cell Carcinoma, Oral Mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Alfacalcidol Drops,1ug a day,40day
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Alfacalcidol Oral Solution
Intervention Description
Alfacalcidol Oral Solution 1ug a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Within two months from the start of chemotherapy
Description
Oral mucosal hyperemia, erythema, erosion, ulceration and fibrosis appear, accompanied by clinical manifestations such as pain, difficulty eating, dry mouth, and taste disturbance.
Time Frame
Within two months from the start of chemotherapy
Secondary Outcome Measure Information:
Title
Grading of oral mucositis in patients treated with vitamin D and placebo
Description
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
Time Frame
Within two months from the start of chemotherapy
Title
Changes in the quality of life of patients in vitamin D treatment group and placebo group before
Description
University of Washington quality of life scale
Time Frame
Within two months from the start of chemotherapy
Title
Healing time of oral mucositis in vitamin D treatment group and placebo group
Description
Time to cure of patients with oral mucositis
Time Frame
Within two months from the end of chemotherapy
Title
Length of hospital stay of patients in vitamin D treatment group and placebo group
Description
Length of hospital stay
Time Frame
Within two months from the start of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhiquan huang, PH.D
Phone
13826142898
Email
hzhquan@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs