Clinical trial NCT02854410: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: dietary sodium nitrate
radiotherapy
nasopharyngeal carcinoma
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Beijing Friendship Hospital
First posted: 2016-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change of salivary flow
timeFrame: 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:
measure: Chang of plasm nitrate level
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University School of Stomatology
state: Beijing
Study officials:
affiliation: Capital Medical University shool of stomatology
name: Wang Songlin, PHD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.