Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Receiving Concurrent Chemo-radiotherapy

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Dietary Supplement: nitrate supplementation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitrate supplementation<br>Patients will receive 7-day nitrate supplementation at the end of the radiotherapy. | Dietary Supplement: nitrate supplementation<br>* A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.<br>|
| Placebo Comparator: Placebo<br>Patients will receive 7-day placebo supplementation at the end of the radiotherapy | Dietary Supplement: Placebo<br>* A 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma nitrate level | The plasma nitrate level will be determined one day after nitrate supplementation. | one day after nitrate supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | The quality of life will be assessed one day after nitrate supplementation. | one day after nitrate supplementation | 

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