Nasopharyngeal Carcinoma
Conditions
Keywords
dietary sodium nitrate, radiotherapy, nasopharyngeal carcinoma
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.
Interventions
DIETARY_SUPPLEMENTSodium nitrate
Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid
DIETARY_SUPPLEMENTsodium chloride
Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Friendship Hospital
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactChang Shimin, PHD
Outcome results
None listed