Sodium selenite supplementation for patients with head and neck cancer
The Role of Sodium Selenite Supplementation in Patients With Locally Advanced Head and Neck Cancer Undergoing Concurrent Chemoradiotherapy
This study tests if taking sodium selenite can help people with head and neck cancer feel better and handle treatment side effects while they are undergoing chemotherapy and radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Keelung) |
| Trial ID | NCT05451576 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sodium selenite supplementation in patients diagnosed with head and neck squamous cell carcinoma who are undergoing concurrent chemoradiotherapy. It aims to evaluate whether selenium, an essential trace element, can reduce treatment toxicity and improve the quality of life for these patients. The study includes a comparison between sodium selenite and a placebo to assess its impact on immune response and side effects associated with treatment. Eligible participants are those aged 20-75 with specific cancer stages and adequate organ function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-75 with histologically confirmed head and neck squamous cell carcinoma scheduled for concurrent chemoradiotherapy.
Not a fit: Patients with nasopharyngeal cancer or those with a history of selenium allergy or intolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment tolerance and improve overall quality of life for patients undergoing chemoradiotherapy for head and neck cancer.
How similar studies have performed: Previous studies have shown mixed results regarding selenium supplementation in head and neck cancer, indicating both potential benefits and negative responses.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Keelung
- Chang Gung Memorial Hospital — Keelung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hang Huong Ling, MD — Chang Gung Memorial Hospital
- Study coordinator: Li-Ting Lian
- Email: liting@cgmh.org.tw
- Phone: +886-224329292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.