Sodium FluoridePhase 2NCT06174012
The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in NPC Patients
A Phase 2 study testing Sodium Fluoride in people with Sodium Fluoride, run by Sun Yat-sen University.
Trial summary
To evaluate the efficacy of sodium fluoride to preventing radiation caries for patients with nasopharyngeal carcinoma receiving radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sodium Fluoride
- What is being tested?
- Sodium Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a. Patients with histologically confirmed non-keratinizing NPC (including differentiated type and undifferentiated type, world health organization [WHO] II or III).
- 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.
- With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine< 1.5×ULN.
- The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to 1.
- Patients must be informed of the investigational nature of this study and give written informed consent.
- 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.
Who cannot join
- 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.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- 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).
- Fewer than 2 functional teeth in any 1/6 segment of the mouth after pre-radiotherapy scaling.
- 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).
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Sodium Fluoride
- Being tested
- Sodium Fluoride
- Keywords
- Nasopharyngeal Carcinoma, Sodium Fluoride, Radiation Caries
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium FluorideDrug
Sodium fluoride was applied before radiotherapy, at 3 months, 6 months, and 12 months after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Fluoride Group | Experimental | Not described Receives: Drug: Sodium Fluoride |
| Conventional care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radiation caries
Incidence of radiation caries will be assessed by DMFT index.
Measured: 3、6、12 months after radiotherapy
Secondary outcomes (1)
Correlation between radiation-induced otitis media and life quality after radiotherapy
The life quality will be assessed by OHIP-14.
Measured: 3、6、12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium FluorideStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174012
- Sponsor's protocol ID
- 2023-FXY-139
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in Nasopharyngeal Carcinoma Patients: A Prospective, Open, Randomized Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT06174012
- Acronym / sponsor ID
- 2023-FXY-139
- Conditions
- Sodium Fluoride
- Keywords
- Nasopharyngeal Carcinoma, Sodium Fluoride, Radiation Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of sodium fluoride to preventing radiation caries for patients with nasopharyngeal carcinoma receiving radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Fluoride Group | Experimental | Drug: Sodium Fluoride |
| Conventional care group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- a. Patients with histologically confirmed non-keratinizing NPC (including differentiated type and undifferentiated type, world health organization [WHO] II or III).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium FluorideSodium fluoride was applied before radiotherapy, at 3 months, 6 months, and 12 months after radiotherapy. | Drug | Sodium Fluoride Group |
Primary outcome
Incidence of radiation caries
Time frame: 3、6、12 months after radiotherapy
Incidence of radiation caries will be assessed by DMFT index.
1 secondary outcome
Correlation between radiation-induced otitis media and life quality after radiotherapy
Time frame: 3、6、12 months after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Fluoride in people with Sodium Fluoride, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiu-Yan Chen, Dr (86-20-8734-3380, chenqy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radiation caries (time frame: 3、6、12 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.