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

NCT06174012 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023-FXY-139
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sodium Fluoride

Keywords

Nasopharyngeal Carcinoma; Sodium Fluoride; Radiation Caries

Outcome Measures

Primary Outcomes (1)

• Incidence of radiation caries

  Incidence of radiation caries will be assessed by DMFT index.

  3、6、12 months after radiotherapy

Secondary Outcomes (1)

• Correlation between radiation-induced otitis media and life quality after radiotherapy

  3、6、12 months after radiotherapy

Study Arms (2)

Sodium Fluoride Group

EXPERIMENTAL

Drug: Sodium Fluoride

Conventional care group

NO INTERVENTION

Interventions

Sodium Fluoride DRUG

Sodium fluoride was applied before radiotherapy, at 3 months, 6 months, and 12 months after radiotherapy.

Sodium Fluoride Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Qiu-Yan Chen, Dr

CONTACT

86-20-8734-3380; chenqy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: December 15, 2023
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share