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
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.
Study Type
Interventional
Primary Outcome
Change of salivary flow
Secondary Outcome
Chang of plasm nitrate level
Condition
Nasopharyngeal Carcinoma
Intervention
Sodium nitrate
Study Arms / Comparison Groups
Sodium nitrate supplementation
Description: Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
30
Start Date
August 2016
Completion Date
December 2018
Primary Completion Date
August 2018
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.
Gender
All
Ages
20 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Wang Songlin, PHD, 13520538923, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02854410
Organization ID
changsm2005
Responsible Party
Principal Investigator
Study Sponsor
Capital Medical University
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sponsor
Wang Songlin, PHD, Study Chair, Capital Medical University shool of stomatology
Verification Date
July 2016