Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

Not Applicable

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Dietary Supplement: sodium chloride; Dietary Supplement: Sodium nitrate

• Registration Number: NCT02854410
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-23
• Study First Submitted QC: 2016-07-31
• Last Update Submitted: 2016-07-31
• Study Start: 2016-08
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator(sodium chloride)	sodium chloride	Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy
Sodium nitrate supplementation	Sodium nitrate	Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Capital Medical University School of Stomatology; 🇨🇳 Beijing, Beijing, China