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

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

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

Conditions
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Sodium Fluoride

Intervention / Treatment
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* Drug: Sodium Fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, Sodium Fluoride, Radiation Caries