Dietary Nitrate on Salivary Flow 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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sodium nitrate supplementation

Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy

Group Type EXPERIMENTAL

Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid

Placebo Comparator(sodium chloride)

Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy

Group Type PLACEBO_COMPARATOR

sodium chloride

Intervention Type DIETARY_SUPPLEMENT

Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid

Interventions

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Sodium nitrate

Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid

Intervention Type DIETARY_SUPPLEMENT

sodium chloride

Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid

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 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No