Sodium Selenite Supplementation in Patients With Head and Neck Cancer

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called sodium selenite, which contains the mineral selenium, in patients with locally advanced head and neck cancer. Researchers want to see if giving this supplement through an intravenous (IV) method can help reduce side effects during treatment and improve overall health outcomes for patients undergoing concurrent chemoradiotherapy (CCRT). They are particularly interested in how it affects treatment-related issues, quality of life, and long-term survival rates.

To be eligible for the trial, participants must be between the ages of 20 and 75 and have a confirmed diagnosis of head and neck squamous cell carcinoma. They should also be scheduled to start CCRT and have certain health criteria met, like having good blood counts and organ function. Those who join the study will receive sodium selenite and be monitored for various health markers and potential benefits during their treatment. It's important to note that certain patients, such as those with specific types of cancer or serious health issues, will not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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).