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Trial Title:
Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma
NCT ID:
NCT06016400
Condition:
Oral Squamous Cell Carcinoma
Oral Mucositis
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Mucositis
Stomatitis
Inflammation
Alfacalcidol
Hydroxycholecalciferols
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Alfacalcidol Oral Solution
Description:
Alfacalcidol Oral Solution 1ug a day
Arm group label:
intervention group
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
control group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
zhiquan huang, PH.D
Phone:
13826142898
Email:
hzhquan@mail.sysu.edu.cn
Start date:
June 14, 2021
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06016400
