Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

Capital Medical University

Status: Unknown

Conditions: Nasopharyngeal Carcinoma

Treatments: Dietary Supplement: sodium chloride; Dietary Supplement: Sodium nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02854410

changsm2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Sodium nitrate supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sodium nitrate

Placebo Comparator(sodium chloride)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: sodium chloride