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Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium nitrate
sodium chloride
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasopharyngeal Carcinoma focused on measuring dietary sodium nitrate, radiotherapy, nasopharyngeal carcinoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Capital Medical University School of Stomatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium nitrate supplementation

Placebo Comparator(sodium chloride)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of salivary flow

Secondary Outcome Measures

Chang of plasm nitrate level

Full Information

First Posted
July 23, 2016
Last Updated
July 31, 2016
Sponsor
Capital Medical University
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02854410
Brief Title
Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients
Official Title
Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients Pre and Post Concurrent Chemo-radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
dietary sodium nitrate, radiotherapy, nasopharyngeal carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium nitrate supplementation
Arm Type
Experimental
Arm Description
Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy
Arm Title
Placebo Comparator(sodium chloride)
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium nitrate
Intervention Description
Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid
Intervention Type
Dietary Supplement
Intervention Name(s)
sodium chloride
Intervention Description
Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Shimin, PHD
Phone
13520538923
Email
changsm2005@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Songlin, PHD
Organizational Affiliation
Capital Medical University shool of stomatology
Official's Role
Study Chair
Facility Information:
Facility Name
Capital Medical University School of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12562881
Citation
Xia DS, Deng DJ, Wang SL. Destruction of parotid glands affects nitrate and nitrite metabolism. J Dent Res. 2003 Feb;82(2):101-5. doi: 10.1177/154405910308200205.
Results Reference
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PubMed Identifier
17134590
Citation
Xia DS, Liu Y, Zhang CM, Yang SH, Wang SL. Antimicrobial effect of acidified nitrate and nitrite on six common oral pathogens in vitro. Chin Med J (Engl). 2006 Nov 20;119(22):1904-9.
Results Reference
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PubMed Identifier
12542832
Citation
Xia D, Deng D, Wang S. Alterations of nitrate and nitrite content in saliva, serum, and urine in patients with salivary dysfunction. J Oral Pathol Med. 2003 Feb;32(2):95-9. doi: 10.1034/j.1600-0714.2003.00109.x.
Results Reference
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PubMed Identifier
26189149
Citation
Bryan NS, Ivy JL. Inorganic nitrite and nitrate: evidence to support consideration as dietary nutrients. Nutr Res. 2015 Aug;35(8):643-54. doi: 10.1016/j.nutres.2015.06.001. Epub 2015 Jun 11.
Results Reference
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PubMed Identifier
26261499
Citation
Xia D, Qu X, Tran SD, Schmidt LL, Qin L, Zhang C, Cui X, Deng D, Wang S. Histological characteristics following a long-term nitrate-rich diet in miniature pigs with parotid atrophy. Int J Clin Exp Pathol. 2015 Jun 1;8(6):6225-34. eCollection 2015. Erratum In: Int J Clin Exp Pathol. 2019 Dec 01;12(12):4405-4406.
Results Reference
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Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

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