Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the salivary flow for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Detailed Description
-----------------
Thirty patients diagnosed as nasopharyngeal carcinoma will be recruited. Nitrate supplement(Sodium nitrate: 0.5 mmol/kgbodyweight,bid) or placebo(sodium chloride: 0.5 mmol/kgbodyweight,bid) will be provided to the patients from 7 days before radiotherapy to one month after the finish of radiotherapy . The salivary flow and plasma nitrate levels will be determined before the course of nitrate supplementation and radiotherapy,before the course of radiotherapy,post the course of radiotherapy immediately and one month after the finish of radiotherapy.

Official Title
-----------------
Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients Pre and Post Concurrent Chemo-radiation Therapy

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Dietary Supplement: Sodium nitrate
* Dietary Supplement: sodium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited. Exclusion Criteria: Patients with local invasion or metastatic foci in salivary glands, detected by MRI and positron emission computed tomography(PET-CT) prior to treatment, were excluded, as were patients suffering from diseases, such as Sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium nitrate supplementation<br>Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy | Dietary Supplement: Sodium nitrate<br>* Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid<br>|
| Placebo Comparator: Placebo Comparator(sodium chloride)<br>Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy | Dietary Supplement: sodium chloride<br>* Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of salivary flow |  | one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chang of plasm nitrate level |  | one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary sodium nitrate, radiotherapy, nasopharyngeal carcinoma