Trial Title:
Oxidative Stress and Inflammation Biomarkers in Surgically Treated Patients With Laryngeal Cancer
NCT ID:
NCT05857202
Condition:
Oxidative Stress Induction
Laryngeal Cancer
Interleukins
Pain Management
Quality of Life
Pain, Postoperative
Conditions: Official terms:
Laryngeal Neoplasms
Inflammation
Pain, Postoperative
Analgesics, Opioid
Analgesics
Analgesics, Non-Narcotic
Conditions: Keywords:
oxidative stress
laryngeal cancer
pain management
interleukins
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Analgesics, Opioid
Description:
Drugs were given immediately after the surgery, and correlation between analgesic use and
parameters of oxidative stress and inflammation was assessed.
Arm group label:
Operated laryngeal cancer patients treated with non narcotic and opioids
Arm group label:
Operated laryngeal cancer patients treated with opioids
Intervention type:
Drug
Intervention name:
Analgesics, Non-Narcotic
Description:
Drugs were given immediately after the surgery, and correlation between analgesic use and
parameters of oxidative stress and inflammation was assessed.
Arm group label:
Operated laryngeal cancer patients treated with non narcotic
Arm group label:
Operated laryngeal cancer patients treated with non narcotic and opioids
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 - H&N35) 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.
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 (745/5-22), 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 - H&N35) 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 manufacturer's 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 9.0 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 Spearman's rank correlation coefficient was used, because
variables didn't 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 0.05. The analysis was performed in
IBM SPSS ver. 26.
Criteria for eligibility:
Study pop:
The study would include 100 patients with squamocellular carcinoma of the larynx
surgically treated at the tertiary referral center. The diagnosis of laryngeal carcinoma
was confirmed by otorhinolaryngological clinical examination, laryngomicroscopic
examination with the biopsy and histopathologic examination. 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.
The modality of surgical treatment was decided on the institutional Oncological Board and
involved resection of the tumor (cordectomy, partial or total laryngectomy) with or
without some form of the neck dissection in case of cervical lymphadenopathy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- patients with all stages of diagnosed and operable laryngeal squamocellular
carcinoma (T1-T4, N0-N2)
Exclusion Criteria:
- 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
- the inability to provide informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinic for otorhinolaryngology and maxillofacial surgery, Clinical Center of Serbia
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Contact:
Last name:
Ana D Jotic, MD, PhD
Phone:
+381637789825
Email:
anajotic@yahoo.com
Facility:
Name:
Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Contact:
Last name:
Katarina R Savic Vujovic, MD, PhD
Phone:
+381 63 776 3960
Email:
katarinasavicvujovic@gmail.com
Investigator:
Last name:
Andjela T Zivkovic, MD
Email:
Sub-Investigator
Start date:
September 1, 2022
Completion date:
October 30, 2023
Lead sponsor:
Agency:
Clinical Centre of Serbia
Agency class:
Other
Collaborator:
Agency:
Faculty of Medicine, University of Belgrade
Agency class:
Other
Source:
Clinical Centre of Serbia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857202
