Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients

Not Applicable

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Dietary Supplement: nitrate supplementation; Dietary Supplement: Placebo

• Registration Number: NCT02044562
• Lead Sponsor: Capital Medical University

Brief Summary

The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Detailed Description

Twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. A 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . The plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Last Update Submitted: 2014-01-22
• Study First Posted: 2014-01-24
• Last Update Posted: 2014-01-24
• Primary Completion: 2014-08
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 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
nitrate supplementation	nitrate supplementation	Patients will receive 7-day nitrate supplementation at the end of the radiotherapy.
Placebo	Placebo	Patients will receive 7-day placebo supplementation at the end of the radiotherapy

Primary Outcome Measures

Name	Time	Method
plasma nitrate level	one day after nitrate supplementation	The plasma nitrate level will be determined one day after nitrate supplementation.

Secondary Outcome Measures

Name	Time	Method
quality of life	one day after nitrate supplementation	The quality of life will be assessed one day after nitrate supplementation.

Trial Locations

Locations (1)

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