Sodium Selenite Supplementation in Patients With Head and Neck Cancer

NCT05451576 | Unknown

• 1 other identifier: 202000865A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Selenium; Sodium Selenite

Keywords

Sodium selenite; Selenium; chemoradiotherapy; head and neck cancer

Outcome Measures

Primary Outcomes (13)

• Toxicities

  Mucositis, pharyngitis, dermatitis, xerostomia, fatigue, infection, and cytopenia by Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0)

  Week 1 to Week 8

• Pain assessment

  Visual analogue scale (VAS): score ranges 0-10 (higher value indicates worse outcome)

  Week 1 to Week 8

• Quality of life changes

  European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43), reported in mean values (higher value indicates worse outcome)

  Week 1 to Week 8

• Serum concentration changes of selenium

  Serum levels of selenium during concurrent chemoradiotherapy

  Week 1 to Week 8

• Changes of albumin

  Serum albumin (g/dL) changes during concurrent chemoradiotherapy

  Week 1 to Week 12

• Changes of transferrin

  Serum transferrin (mg/dL) changes during concurrent chemoradiotherapy

  Week 1 to Week 12

• Changes of total cholesterol

  Total cholesterol (mg/dL) changes during concurrent chemoradiotherapy

  Week 1 to Week 12

• Change of interferon-γ (IFNγ)

  IFNγ (pg/mL) changes during concurrent chemoradiotherapy

  Week 1 to Week 8

• Changes of tumor necrosis factor-α (TNFα)

  TNFα (pg/mL) changes during concurrent chemoradiotherapy

  Week 1 to Week 8

• Changes of interleukin-2 (IL-2)

  IL-2 (pg/mL) changes during concurrent chemoradiotherapy

  Week 1 to Week 8

• Changes of interleukin-6 (IL-6)

  IL-6 (pg/mL) changes during concurrent chemoradiotherapy

  Week 1 to Week 8

• Changes of granzyme B

  Granzyme B (pg/mL) changes during concurrent chemoradiotherapy

  Week 1 to Week 8

• Immune cells changes during concurrent chemoradiotherapy

  By using Maxpar Direct Immune Profiling Assay to identify 30 subsets of immune cells

  Week 1 to Week 8

Secondary Outcomes (2)

• Disease-free survival

  0 to 3 years

• Overall survival

  0 to 3 years

Study Arms (2)

Sodium selenite

ACTIVE COMPARATOR

200μg/d intravenous sodium selenite was dissolved in 100 ml 0.09% NaCl run 30 minutes, will be given on day 1-5, day 8-12, day 15-19, day 22-26, day 29-33, day 36-40, day 43-47 during concurrent chemoradiotherapy.

Dietary Supplement: Zelnite®

Placebo

PLACEBO COMPARATOR

100 ml intravenous 0.09% NaCl run 30 minutes, will be given on day 1-5, day 8-12, day 15-19, day 22-26, day 29-33, day 36-40, day 43-47 during concurrent chemoradiotherapy.

Dietary Supplement: Placebo

Interventions

Zelnite® DIETARY_SUPPLEMENT

2pc intravenous Zelnite® will be given for 7 weeks (5 days/week).

Sodium selenite

Placebo DIETARY_SUPPLEMENT

Placebo will be given for 7 weeks (5 days/week).

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 204, Taiwan

RECRUITING

Related Publications (8)

• Kiremidjian-Schumacher L, Roy M, Glickman R, Schneider K, Rothstein S, Cooper J, Hochster H, Kim M, Newman R. Selenium and immunocompetence in patients with head and neck cancer. Biol Trace Elem Res. 2000 Feb;73(2):97-111. doi: 10.1385/BTER:73:2:97.

  PMID: 11049203 BACKGROUND

• Elango N, Samuel S, Chinnakkannu P. Enzymatic and non-enzymatic antioxidant status in stage (III) human oral squamous cell carcinoma and treated with radical radio therapy: influence of selenium supplementation. Clin Chim Acta. 2006 Nov;373(1-2):92-8. doi: 10.1016/j.cca.2006.05.021. Epub 2006 May 19.

  PMID: 16831410 BACKGROUND

• Micke O, Bruns F, Mucke R, Schafer U, Glatzel M, DeVries AF, Schonekaes K, Kisters K, Buntzel J. Selenium in the treatment of radiation-associated secondary lymphedema. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):40-9. doi: 10.1016/s0360-3016(02)04390-0.

  PMID: 12694822 BACKGROUND

• Zimmermann T, Leonhardt H, Kersting S, Albrecht S, Range U, Eckelt U. Reduction of postoperative lymphedema after oral tumor surgery with sodium selenite. Biol Trace Elem Res. 2005 Sep;106(3):193-203. doi: 10.1385/BTER:106:3:193.

  PMID: 16141467 BACKGROUND

• Buntzel J, Riesenbeck D, Glatzel M, Berndt-Skorka R, Riedel T, Mucke R, Kisters K, Schonekaes KG, Schafer U, Bruns F, Micke O. Limited effects of selenium substitution in the prevention of radiation-associated toxicities. results of a randomized study in head and neck cancer patients. Anticancer Res. 2010 May;30(5):1829-32.

  PMID: 20592387 BACKGROUND

• Weijl NI, Elsendoorn TJ, Lentjes EG, Hopman GD, Wipkink-Bakker A, Zwinderman AH, Cleton FJ, Osanto S. Supplementation with antioxidant micronutrients and chemotherapy-induced toxicity in cancer patients treated with cisplatin-based chemotherapy: a randomised, double-blind, placebo-controlled study. Eur J Cancer. 2004 Jul;40(11):1713-23. doi: 10.1016/j.ejca.2004.02.029.

  PMID: 15251161 BACKGROUND

• Mix M, Singh AK, Tills M, Dibaj S, Groman A, Jaggernauth W, Rustum Y, Jameson MB. Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck. World J Clin Oncol. 2015 Oct 10;6(5):166-73. doi: 10.5306/wjco.v6.i5.166.

  PMID: 26468453 BACKGROUND

• Dennert G, Horneber M. Selenium for alleviating the side effects of chemotherapy, radiotherapy and surgery in cancer patients. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD005037. doi: 10.1002/14651858.CD005037.pub2.

  PMID: 16856073 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Hang Huong Ling, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Ting Lian

CONTACT

+886-224329292; liting@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: August 12, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)