Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

July 31, 2016 updated by: Songlin Wang, Capital Medical University

Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients Pre and Post Concurrent Chemo-radiation Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Capital Medical University School of Stomatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium nitrate supplementation
Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy
Dietary supplement: Sodium nitrate
Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid
Placebo Comparator: Placebo Comparator(sodium chloride)
Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy
Dietary supplement: sodium chloride
Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of salivary flow
Time Frame: 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
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

Outcome Measure
Time Frame
Chang of plasm nitrate level
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Collaborators

Beijing Friendship Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Wang Songlin, PHD, Capital Medical University shool of stomatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 23, 2016

First Submitted That Met QC Criteria

July 31, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 31, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • changsm2005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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