Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients

Capital Medical University

Status: Unknown

Conditions: Nasopharyngeal Carcinoma

Treatments: Dietary Supplement: nitrate supplementation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02044562

13-07-08

Details and patient eligibility

About

The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Full description

Twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. A 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . The plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 60 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 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

nitrate supplementation

Experimental group

Description:

Patients will receive 7-day nitrate supplementation at the end of the radiotherapy.

Treatment:

Dietary Supplement: nitrate supplementation

Placebo

Placebo Comparator group

Description:

Patients will receive 7-day placebo supplementation at the end of the radiotherapy

Treatment:

Dietary Supplement: Placebo