Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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nitrate supplementation

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

Group Type EXPERIMENTAL

nitrate supplementation

Intervention Type DIETARY_SUPPLEMENT

A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.

Interventions

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nitrate supplementation

A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.

Intervention Type DIETARY_SUPPLEMENT

Placebo

A 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No