Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05857202
Status:
RECRUITING
Last Update Posted:
2023-05-12
First Post:
2023-03-29
Brief Title:
Oxidative Stress and Inflammation Biomarkers in Surgically Treated Patients With Laryngeal Cancer
Sponsor:
Clinical Centre of Serbia
Organization:
Clinical Centre of Serbia
Study Overview
Official Title:
Oxidative Stress and Inflammation Biomarkers in Correlation to Postoperative Pain Modulation in Surgically Treated Patients With Laryngeal Cancer
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A experimental interventional prospective study will include patients with squamocellular carcinoma of the larynx surgically treated at the tertiary referral center Clinical and demographic characteristics of the patients would be noted The visual analog scale VAS Brief Pain Inventory questionnaire Diagnosing Neuropathic Pain 4 DN4 and Pain Detect Questionnaire were used for pain assessment Questionnaire Quality of Life in Head and Neck Cancer Patients QLQ - HN35 was used to assess the quality of life in patients with surgically treated laryngeal carcinoma The type and consumption of analgesics used after surgery was monitored The analgesics were used according to WHO Ladder Blood samples ware taken from the patients for the analysis of oxidative stress parameters and inflammation parameters before the operative treatment and after the operative treatment 1-2 postoperative day and 9-10 postoperative day The concentrations of interleukin 1 IL-1 and 6 IL-6 glutathione peroxidase 1 GPX1 superoxide dismutase 1 SOD1 and malondialdehyde MDA in the serum were determined
The aim of the study will be to assess concentrations of inflammatory biomarkers IL-1 IL-6 and oxidative stress factors MDA SOD GPKS1 in postoperative course in surgically treated patients with laryngeal carcinoma and in possible complication occurrence Also their correlation to type and dosage of used analgesics to pain assessment questionnaire scores and QOL questionnaire scores in surgically treated patients with laryngeal carcinoma will be assessed
The aim of the study will be to assess concentrations of inflammatory biomarkers IL-1 IL-6 and oxidative stress factors MDA SOD GPKS1 in postoperative course in surgically treated patients with laryngeal carcinoma and in possible complication occurrence Also their correlation to type and dosage of used analgesics to pain assessment questionnaire scores and QOL questionnaire scores in surgically treated patients with laryngeal carcinoma will be assessed
Detailed Description:
Patient selection
A experimental interventional prospective study would include 100 patients with squamocellular carcinoma of the larynx surgically treated in the period from October 2022 to February 2023 at the tertiary referral center This study was approved by the Institutional Ethics Committee 7455-22 and all patients signed the informed consent form prior to their inclusion in the study The diagnosis of laryngeal carcinoma was confirmed by otorhinolaryngological clinical examination and laryngomicroscopic examination of the larynx with the biopsy and histopathologic examination of the tissue Additional diagnostics chest radiography and computed tomography of the neck and ultrasonography of the abdomen were performed to determine the TNM stage of the disease Study included patients with all stages of operable laryngeal carcinoma T1-T4 N0-N2 without previous treated malignancies Exclusion criteria were inoperable malignant disease presence of distant metastases previously treated malignancies presence of neurological or other severe comorbidities which prevent surgical treatment the presence of neurological or other severe physical and metabolic comorbidities substance abuse and the inability to provide informed consent
The modality of treatment for every patient was decided on the institutional Oncological Board consisting of a radiotherapist head and neck surgeons an oncologist and a histopathologist Open surgical treatment involved resection of the tumor cordectomy partial or total laryngectomy with or without some form of the neck dissection in case of cervical lymphadenopathy Demographic clinical and histopathological characteristics age and gender tobacco use histopathological tumor grade TNM classification and therapy modality were noted
Quality of life assessment
Questionnaire Quality of Life in Head and Neck Cancer Patients QLQ - HN35 was used to assess the quality of life in patients with surgically treated laryngeal carcinoma
Pain assessment
The visual analog scale VAS was used for pain assessment Scores were based on self-reported measures of pain severety that are recorded with a mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale 0 cm on the left end of the scale marks no pain and 10 cm on the right end of the scale marks the worst pain
Brief Pain Inventory questionnaire Diagnosing Neuropathic Pain 4 DN4 and Pain Detect Questionnaire were used for quality assessment of postoperative pain
Postoperative analgesia
The type and consumption of analgesics used after surgery was monitored The analgesics were used according to WHO Ladder 1 for mild to moderate pain a non-opioid acetaminophen or non-steroid anti-inflammatory drug NSAID with or without an adjuvant 2 for moderate or severe pain a non-opioid with an opioid for moderate pain and 3 an opioid for moderate to severe pain not combined with another agent
Measurement of the Oxidative Stress and Inflammatory Parameters
Blood was taken from the patients for the analysis of oxidative stress parameters and inflammation parameters before the operative treatment and after the operative treatment 1-2 postoperative day and 9-10 postoperative day The concentrations of interleukin 1 IL-1 and 6 IL-6 glutathione peroxidase 1 GPX1 superoxide dismutase 1 SOD1 and malondialdehyde MDA in the serum were determined by coated enzyme-linked immunosorbent assay ELISA kits according to the manufacturers instructions Elabscience Wuhan China The ELISA kits for determination of concentrations of IL-1 and IL-6 were based on the Sandwich ELISA principle with plates pre-coated with an antibody specific to human cytokines The optical density OD was measured spectrophotometrically at 450 nm using a Multiskan EX plate reader Thermo Fisher Scientific Vantaa Finland The concentration of analytesin of the tested samples was calculated by comparing the OD of the samples to the standard curve created with GraphPad Prism 90 software GraphPad Software Inc San Diego CA USA
Statistical analysis
Categorical data was described by absolute and relative numbers in percentages while numerical data was reported as arithmetic mean and standard deviation or median and interquartile range IQR depending on the data distribution The normality was evaluated using mathematical Shapiro-Willk skewness and kurtosis and coefficient of variation and graphical histogram box plot methods For the evaluation of changing of pain intensity parameters of oxidative stress and biomarkers of inflammation Friedman test was applied with Wilcoxon signed rank test as post-hoc testing method For analyzing the association between pain intensity VAS parameters of oxidative stress and biomarkers of inflammation Spearmans rank correlation coefficient was used because variables didnt have normal distribution In order to evaluate all possible factors that influence the level of oxidative stress expressed as SOD and MDA levels linear regression analysis enter method was performed reporting regression coefficient B 95 confidence level CI of B and p value Univariate analysis was done first and all significant factors were combined in multivariate models All statistical methods were considered significant if p value was less or equal 005 The analysis was performed in IBM SPSS ver 26
A experimental interventional prospective study would include 100 patients with squamocellular carcinoma of the larynx surgically treated in the period from October 2022 to February 2023 at the tertiary referral center This study was approved by the Institutional Ethics Committee 7455-22 and all patients signed the informed consent form prior to their inclusion in the study The diagnosis of laryngeal carcinoma was confirmed by otorhinolaryngological clinical examination and laryngomicroscopic examination of the larynx with the biopsy and histopathologic examination of the tissue Additional diagnostics chest radiography and computed tomography of the neck and ultrasonography of the abdomen were performed to determine the TNM stage of the disease Study included patients with all stages of operable laryngeal carcinoma T1-T4 N0-N2 without previous treated malignancies Exclusion criteria were inoperable malignant disease presence of distant metastases previously treated malignancies presence of neurological or other severe comorbidities which prevent surgical treatment the presence of neurological or other severe physical and metabolic comorbidities substance abuse and the inability to provide informed consent
The modality of treatment for every patient was decided on the institutional Oncological Board consisting of a radiotherapist head and neck surgeons an oncologist and a histopathologist Open surgical treatment involved resection of the tumor cordectomy partial or total laryngectomy with or without some form of the neck dissection in case of cervical lymphadenopathy Demographic clinical and histopathological characteristics age and gender tobacco use histopathological tumor grade TNM classification and therapy modality were noted
Quality of life assessment
Questionnaire Quality of Life in Head and Neck Cancer Patients QLQ - HN35 was used to assess the quality of life in patients with surgically treated laryngeal carcinoma
Pain assessment
The visual analog scale VAS was used for pain assessment Scores were based on self-reported measures of pain severety that are recorded with a mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale 0 cm on the left end of the scale marks no pain and 10 cm on the right end of the scale marks the worst pain
Brief Pain Inventory questionnaire Diagnosing Neuropathic Pain 4 DN4 and Pain Detect Questionnaire were used for quality assessment of postoperative pain
Postoperative analgesia
The type and consumption of analgesics used after surgery was monitored The analgesics were used according to WHO Ladder 1 for mild to moderate pain a non-opioid acetaminophen or non-steroid anti-inflammatory drug NSAID with or without an adjuvant 2 for moderate or severe pain a non-opioid with an opioid for moderate pain and 3 an opioid for moderate to severe pain not combined with another agent
Measurement of the Oxidative Stress and Inflammatory Parameters
Blood was taken from the patients for the analysis of oxidative stress parameters and inflammation parameters before the operative treatment and after the operative treatment 1-2 postoperative day and 9-10 postoperative day The concentrations of interleukin 1 IL-1 and 6 IL-6 glutathione peroxidase 1 GPX1 superoxide dismutase 1 SOD1 and malondialdehyde MDA in the serum were determined by coated enzyme-linked immunosorbent assay ELISA kits according to the manufacturers instructions Elabscience Wuhan China The ELISA kits for determination of concentrations of IL-1 and IL-6 were based on the Sandwich ELISA principle with plates pre-coated with an antibody specific to human cytokines The optical density OD was measured spectrophotometrically at 450 nm using a Multiskan EX plate reader Thermo Fisher Scientific Vantaa Finland The concentration of analytesin of the tested samples was calculated by comparing the OD of the samples to the standard curve created with GraphPad Prism 90 software GraphPad Software Inc San Diego CA USA
Statistical analysis
Categorical data was described by absolute and relative numbers in percentages while numerical data was reported as arithmetic mean and standard deviation or median and interquartile range IQR depending on the data distribution The normality was evaluated using mathematical Shapiro-Willk skewness and kurtosis and coefficient of variation and graphical histogram box plot methods For the evaluation of changing of pain intensity parameters of oxidative stress and biomarkers of inflammation Friedman test was applied with Wilcoxon signed rank test as post-hoc testing method For analyzing the association between pain intensity VAS parameters of oxidative stress and biomarkers of inflammation Spearmans rank correlation coefficient was used because variables didnt have normal distribution In order to evaluate all possible factors that influence the level of oxidative stress expressed as SOD and MDA levels linear regression analysis enter method was performed reporting regression coefficient B 95 confidence level CI of B and p value Univariate analysis was done first and all significant factors were combined in multivariate models All statistical methods were considered significant if p value was less or equal 005 The analysis was performed in IBM SPSS ver 26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None