Head and Neck Squamous Cell CarcinomaNCT05451576
Sodium Selenite Supplementation in Patients With Head and Neck Cancer
A study testing Zelnite® in people with Head and Neck Squamous Cell Carcinoma and Selenium, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Selenium, Sodium Selenite
- What is being tested?
- Zelnite®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Keelung, 204
Hang Huong Ling, MD, +886224329292 ext. 2360, xianfang87@cgmh.org.tw
Yu-Chiau Shyu, PhD
About this study
Official title: The Role of Sodium Selenite Supplementation in Patients With Locally Advanced Head and Neck Cancer Undergoing Concurrent Chemoradiotherapy
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.
Read the detailed description
Selenium is an essential trace element for humans. It is involved in redox regulation, antioxidant functions, membrane integrity, and protection against DNA injury. In both animal models and human studies, it has been shown that selenium has cancer-protective effects and cytoprotective activities. Some mechanisms have been proposed to explain the anti-cancer effects of selenium, which include the antioxidant properties by selenoproteins, induction of conjugating enzymes that detoxify carcinogens, enhancement of the immune response, alterations in DNA methylation and blockage of the cell cycle to allow DNA repair.
There has been conflicting response regarding selenium supplementation on the reduction of toxicity, antitumor efficacy and their quality of life in patients receiving radiotherapy. In the studies by Kiremidjian-Schumacher et al. and Elango et. al, sodium selenite supplementation was shown to significantly enhance cell-mediated immune responsiveness and improve defense systems in head and neck cancer patients. Micke et al. and Zimmerman et al. demonstrated the quality of life of patients suffering from head and neck cancer with lymphedema significantly improved after selenium supplementation. In the study by Büntzel et al., selenium supplementation reduced the radiation-associated side-effects of dysphagia developments in patients with head and neck cancer patients.
However, some studies showed negative response of selenium supplementation in head and neck cancer patients. Weijl et al. showed oral selenium supplementation did not show improvement in cisplatin-induced toxicity or response rate in cancer patients. In the study by Mix et al., addition of oral selenium supplementation was well-tolerated but did not lower the incidence of severe mucositis or improve quality of life or survival outcomes in head and neck cancer patients undergoing concurrent chemoradiation (CRT). An early systematic review in Cochrane demonstrated there was still insufficient evidence to conclude efficacy of selenium in alleviating the side effects of chemotherapy or radiotherapy treatments.
The aim of this study is to investigate the effect of intravenous selenium supplementation on the treatment outcome of head and neck patients undergoing CCRT (toxicities, quality of life, overall survival, progression-free survival), selenium concentration changes during CCRT, and its correlation with nutritional, inflammation and immune markers.
- Being tested
- Zelnite®, Placebo
- Keywords
- Sodium selenite, Selenium, chemoradiotherapy, head and neck cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zelnite®Dietary supplement
2pc intravenous Zelnite® will be given for 7 weeks (5 days/week).
PlaceboDietary supplement
Placebo will be given for 7 weeks (5 days/week).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
Mucositis, pharyngitis, dermatitis, xerostomia, fatigue, infection, and cytopenia by Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0)
Measured: Week 1 to Week 8
Pain assessment
Visual analogue scale (VAS): score ranges 0-10 (higher value indicates worse outcome)
Measured: 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)
Measured: Week 1 to Week 8
Serum concentration changes of selenium
Serum levels of selenium during concurrent chemoradiotherapy
Measured: Week 1 to Week 8
Changes of albumin
Serum albumin (g/dL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 12
Changes of transferrin
Serum transferrin (mg/dL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 12
Changes of total cholesterol
Total cholesterol (mg/dL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 12
Change of interferon-γ (IFNγ)
IFNγ (pg/mL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 8
Changes of tumor necrosis factor-α (TNFα)
TNFα (pg/mL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 8
Changes of interleukin-2 (IL-2)
IL-2 (pg/mL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 8
Changes of interleukin-6 (IL-6)
IL-6 (pg/mL) changes during concurrent chemoradiotherapy
Measured: Week 1 to Week 8
Changes of granzyme B
Granzyme B (pg/mL) changes during concurrent chemoradiotherapy
Measured: 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
Measured: Week 1 to Week 8
Secondary outcomes (2)
Disease-free survival
Measured: 0 to 3 years
Overall survival
Measured: 0 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Aug 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LING HANG HUONG, Chang Gung Memorial Hospital
- Investigators
- Hang Huong Ling, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451576
- Sponsor's protocol ID
- 202000865A3
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11049203Elango 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.
PubMed 16831410Micke 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.
PubMed 12694822Zimmermann 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.
PubMed 16141467Buntzel 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.
PubMed 20592387Weijl 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.
PubMed 15251161Mix 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.
PubMed 26468453Dennert 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.
PubMed 16856073
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sodium Selenite Supplementation in Patients With Locally Advanced Head and Neck Cancer Undergoing Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05451576
- Acronym / sponsor ID
- 202000865A3
- Keywords
- Sodium selenite, Selenium, chemoradiotherapy, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Selenium is an essential trace element for humans. It is involved in redox regulation, antioxidant functions, membrane integrity, and protection against DNA injury. In both animal models and human studies, it has been shown that selenium has cancer-protective effects and cytoprotective activities. Some mechanisms have been proposed to explain the anti-cancer effects of selenium, which include the antioxidant properties by selenoproteins, induction of conjugating enzymes that detoxify carcinogens, enhancement of the immune response, alterations in DNA methylation and blockage of the cell cycle to allow DNA repair.
There has been conflicting response regarding selenium supplementation on the reduction of toxicity, antitumor efficacy and their quality of life in patients receiving radiotherapy. In the studies by Kiremidjian-Schumacher et al. and Elango et. al, sodium selenite supplementation was shown to significantly enhance cell-mediated immune responsiveness and improve defense systems in head and neck cancer patients. Micke et al. and Zimmerman et al. demonstrated the quality of life of patients suffering from head and neck cancer with lymphedema significantly improved after selenium supplementation. In the study by Büntzel et al., selenium supplementation reduced the radiation-associated side-effects of dysphagia developments in patients with head and neck cancer patients.
However, some studies showed negative response of selenium supplementation in head and neck cancer patients. Weijl et al. showed oral selenium supplementation did not show improvement in cisplatin-induced toxicity or response rate in cancer patients. In the study by Mix et al., addition of oral selenium supplementation was well-tolerated but did not lower the incidence of severe mucositis or improve quality of life or survival outcomes in head and neck cancer patients undergoing concurrent chemoradiation (CRT). An early systematic review in Cochrane demonstrated there was still insufficient evidence to conclude efficacy of selenium in alleviating the side effects of chemotherapy or radiotherapy treatments.
The aim of this study is to investigate the effect of intravenous selenium supplementation on the treatment outcome of head and neck patients undergoing CCRT (toxicities, quality of life, overall survival, progression-free survival), selenium concentration changes during CCRT, and its correlation with nutritional, inflammation and immune markers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium selenite | Active comparator | Dietary Supplement: Zelnite®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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo100 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zelnite®2pc intravenous Zelnite® will be given for 7 weeks (5 days/week). | Dietary supplement | Sodium selenite |
| PlaceboPlacebo will be given for 7 weeks (5 days/week). | Dietary supplement | Placebo |
Primary outcome
Toxicities
Time frame: Week 1 to Week 8
Mucositis, pharyngitis, dermatitis, xerostomia, fatigue, infection, and cytopenia by Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0)
Pain assessment
Time frame: Week 1 to Week 8
Visual analogue scale (VAS): score ranges 0-10 (higher value indicates worse outcome)
Quality of life changes
Time frame: Week 1 to Week 8
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)
Serum concentration changes of selenium
Time frame: Week 1 to Week 8
Serum levels of selenium during concurrent chemoradiotherapy
Changes of albumin
Time frame: Week 1 to Week 12
Serum albumin (g/dL) changes during concurrent chemoradiotherapy
Changes of transferrin
Time frame: Week 1 to Week 12
Serum transferrin (mg/dL) changes during concurrent chemoradiotherapy
Changes of total cholesterol
Time frame: Week 1 to Week 12
Total cholesterol (mg/dL) changes during concurrent chemoradiotherapy
Change of interferon-γ (IFNγ)
Time frame: Week 1 to Week 8
IFNγ (pg/mL) changes during concurrent chemoradiotherapy
Changes of tumor necrosis factor-α (TNFα)
Time frame: Week 1 to Week 8
TNFα (pg/mL) changes during concurrent chemoradiotherapy
Changes of interleukin-2 (IL-2)
Time frame: Week 1 to Week 8
IL-2 (pg/mL) changes during concurrent chemoradiotherapy
Changes of interleukin-6 (IL-6)
Time frame: Week 1 to Week 8
IL-6 (pg/mL) changes during concurrent chemoradiotherapy
Changes of granzyme B
Time frame: Week 1 to Week 8
Granzyme B (pg/mL) changes during concurrent chemoradiotherapy
Immune cells changes during concurrent chemoradiotherapy
Time frame: Week 1 to Week 8
By using Maxpar Direct Immune Profiling Assay to identify 30 subsets of immune cells
2 secondary outcomes
Disease-free survival
Time frame: 0 to 3 years
Overall survival
Time frame: 0 to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 11049203Kiremidjian-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.
- Background: PubMed 16831410Elango 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.
- Background: PubMed 12694822Micke 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.
- Background: PubMed 16141467Zimmermann 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.
- Background: PubMed 20592387Buntzel 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.
- Background: PubMed 15251161Weijl 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.
- Background: PubMed 26468453Mix 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.
- Background: PubMed 16856073Dennert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hang Huong Ling, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zelnite® in people with Head and Neck Squamous Cell Carcinoma and Selenium, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Ting Lian (+886-224329292 ext. 2360, liting@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities (time frame: Week 1 to Week 8). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451576, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.