The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in NPC Patients

The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in Nasopharyngeal Carcinoma Patients: A Prospective, Open, Randomized Controlled Phase II Trial

To evaluate the efficacy of sodium fluoride to preventing radiation caries for patients with nasopharyngeal carcinoma receiving radiotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Sodium Fluoride
• Intervention / Treatment: Drug: Sodium Fluoride

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiu-Yan Chen, Dr; Phone Number: 86-20-8734-3380; Email: chenqy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• a. Patients with histologically confirmed non-keratinizing NPC (including differentiated type and undifferentiated type, world health organization [WHO] II or III).

  b. Original clinical staged as II-IVa (according to the 8th AJCC edition) c. Male or female who are not pregnant. d. No evidence of distant metastasis (M0). e. Age between 18-60 years. f. WBC≥4×109/L, PLT≥100×109/L, HGB≥90g/L. g. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

  i. With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine< 1.5×ULN.

  j. The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to 1.

  k. Patients must be informed of the investigational nature of this study and give written informed consent.

  l. Patients receive nasopharyngeal and neck radiotherapy. m. After pre-radiotherapy oral examination, no less than 2 functional teeth in any 1/6 segment of the mouth.

Exclusion Criteria:

• a. With clinical stage of I and IVb (according to the 8 th AJCC edition). b. Patients with tumor recurrence or distant metastasis. c. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

  d. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

  e. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. f. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).

  g. Fewer than 2 functional teeth in any 1/6 segment of the mouth after pre-radiotherapy scaling.

  h. Lesions of infection in the oral cavity at baseline, severe gingivitis (gingival index = 3, i.e., severe inflammation of the gums, marked redness, swelling or ulceration of the gums, and a tendency to bleed automatically).

  i. Age < 18 or age > 60. j. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and mental disturbance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional care group
Experimental: Sodium Fluoride Group	Drug: Sodium Fluoride; Sodium fluoride was applied before radiotherapy, at 3 months, 6 months, and 12 months after radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of radiation caries	Incidence of radiation caries will be assessed by DMFT index.	3、6、12 months after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between radiation-induced otitis media and life quality after radiotherapy	The life quality will be assessed by OHIP-14.	3、6、12 months after radiotherapy

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Sodium Fluoride; Nasopharyngeal Carcinoma; Radiation Caries
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 2023-FXY-139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No