Sodium Selenite Supplementation in Patients With Head and Neck Cancer

The micronutrient selenium is an essential trace element in the human body. There are more than 25 proteins in the human body contain selenium, such as glutathione peroxidase and selenoprotein, which regulate the body's antioxidant and anti-inflammatory properties. Previous literatures had shown cancer patients have lower serum selenium concentrations than normal people, and lower serum selenium levels may be associated with increased cancer mortality. More than 50% of patients with locally advanced head and neck cancer are malnourished before treatment, and these patients often have deficiency of trace elements, including selenium. In these malnourished patients, they may have to endure increased treatment toxicity and treatment interruption when receiving standard concurrent chemoradiotherapy (CCRT). Interruption of treatment may lead to reduced therapeutic efficacy and compromised survival and recurrence rate. Several small studies have investigated whether oral administration of sodium selenite in patients with head and neck cancer undergoing radiation therapy can improve side effects and affect survival rates, but the results are inconsistent. Our study will use the intravenous form of sodium selenite (Zelnite®) to investigate the effect of selenium on the treatment outcomes of locally advanced head and neck cancer patients undergoing CCRT, such as therapy-related toxicities, quality of life, changes in selenium concentration in blood, nutritional, inflammation and immune markers, and tracking long-term survival and recurrence rates.

Sex

All

Minimum age

20 Years

Maximum age

75 Years

Inclusion Criteria:

* Histological proven head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, larynx, or metastatic cervical lymphadenopathy of unknown primary origin) who were scheduled for adjuvant or primary concurrent chemoradiotherapy (CCRT).
* American Joint Committee on Cancer 8th edition stage III, IVA, and IVB patients.
* Age 20-75 years old.
* Adequate hematopoietic or organ function (leukocyte count ≥ 3.0 x 109/L, hemoglobin ≥ 10 g/dL, platelet count ≥ 100 x109/L, serum bilirubin level ≤ 1.5 mg/dL, alanine aminotransferase (ALT) and aspartate aminotransferase levels (AST) ≤ 3 x upper limit of normal, and serum creatinine level ≤ 1.6 mg/dL or creatinine clearance ≥ 60 mL/min/1.73m2).
* ECOG performance status grade≦2.
* Subjects understand this study, agree to join this study and are able to sign the written inform consent form.

Exclusion Criteria:

* Nasopharyngeal cancer.
* History of selenium allergy or intolerance.
* Received selenium supplementation in recent 1 month.
* Uncontrolled infection - according to PI diagnosis
* Heart failure - New York Heart Association class IV
* Impaired liver function (serum total bilirubin \> 2 x upper limit of normal (ULN), ALT and/or AST \> 5 x ULN).
* Impaired renal function: serum creatinine \> 1.5 x ULN.
* Inadequate bone marrow function (white blood cell count \< 2,500 / mm3 (\<2.5 x 10\^9/L), platelets \< 100,000 / mm3 (\< 100 x 10\^9/L) and hemoglobin \< 10 g/dL).

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