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

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ClinicalTrials.gov Identifier: NCT06016400
Recruitment Status : Recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 14, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Within two months from the start of chemotherapy [ 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.


Secondary Outcome Measures :
  1. Grading of oral mucositis in patients treated with vitamin D and placebo [ Time Frame: 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

  2. Changes in the quality of life of patients in vitamin D treatment group and placebo group before [ Time Frame: Within two months from the start of chemotherapy ]
    University of Washington quality of life scale

  3. Healing time of oral mucositis in vitamin D treatment group and placebo group [ Time Frame: Within two months from the end of chemotherapy ]
    Time to cure of patients with oral mucositis

  4. Length of hospital stay of patients in vitamin D treatment group and placebo group [ Time Frame: Within two months from the start of chemotherapy ]
    Length of hospital stay


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016400


Locations
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China, Guangdong
Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China
Contact: zhiquan huang, PH.D    13826142898    hzhquan@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT06016400    
Other Study ID Numbers: 2021-KY-049
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Mucositis
Stomatitis
Inflammation
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pathologic Processes
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Head and Neck Neoplasms
Neoplasms by Site
Alfacalcidol
Hydroxycholecalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients