NCT02854410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 23, 2016

Last Update Submit

July 31, 2016

Conditions

Nasopharyngeal Carcinoma

Keywords

dietary sodium nitrateradiotherapynasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

  • Change of salivary flow

    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 Outcomes (1)

  • Chang of plasm nitrate level

    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

Study Arms (2)

Sodium nitrate supplementation

EXPERIMENTAL

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

Dietary Supplement: Sodium nitrate

Placebo Comparator(sodium chloride)

PLACEBO COMPARATOR

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

Dietary Supplement: sodium chloride

Interventions

Sodium nitrateDIETARY_SUPPLEMENT

Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid

Sodium nitrate supplementation
sodium chlorideDIETARY_SUPPLEMENT

Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid

Placebo Comparator(sodium chloride)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University School of Stomatology

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (5)

  • 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.

    PMID: 12562881BACKGROUND

  • 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.

    PMID: 17134590BACKGROUND

  • 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.

    PMID: 12542832BACKGROUND

  • 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.

    PMID: 26189149BACKGROUND

  • 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.

    PMID: 26261499BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

sodium nitrateSodium Chloride

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Wang Songlin, PHD

    Capital Medical University shool of stomatology

    STUDY CHAIR

Central Study Contacts

Chang Shimin, PHD

CONTACT

13520538923changsm2005@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice President of Capital Medical University

Study Record Dates

First Submitted

July 23, 2016

First Posted

August 3, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

August 3, 2016

Record last verified: 2016-07

Locations

CN(1)