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CTRI Number  CTRI/2024/07/071485 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   A Study of Infections, Antibiotic Prescription And Survival Rate Among Head And Neck Cancer Patients 
Scientific Title of Study   Assessment of Infections, Antimicrobial Prescription Pattern And Survival Rate Among The Head And Neck Cancer Patients: A Retrospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  E Resna Rathnakar 
Designation  Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8136907769  
Fax    
Email  resnaratnakar987@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Uday Venkat Mateti 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8152977460  
Fax    
Email  udayv@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Krishna Sharan 
Designation  Professor and Head of the Department 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448625116  
Fax    
Email  drkrishna.sharan@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed To Be University),Paneer, Deralakatte, Mangaluru, Karnataka 575018 
Juatice KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka 575018 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishna Sharan  Justice KS Hegde Charitable Hospital  Dept. of Radiotherapy and Oncology, Justice KS HEgde Charitable Hospital, KS Hegde Medical Academy, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA 		 9448625116

drkrishna.sharan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences-Institutional Ethics Committee (NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1)All advanced stage HNC patients who are 18 years and above and were treated in the last 5 years in Justice KS Hegde Charitable Hospital
2)Cade sheets containing complete information of HNC patients
3)Patients who have received chemo radiation or radiotherapy 
 
ExclusionCriteria 
Details  1)Participants with incomplete data in case files
2)Participants or caregivers who do not respond to phone calls 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will provide a summary of prescription pattern of antimicrobial agents, prevalence of infections, antimicrobial resistance and survival status of the Head and Neck Cancer patients.  8 months 
 
Secondary Outcome  
Outcome  TimePoints 
Infection will be correlated with the mortality among Head and Neck Cancer  8 months 
 
Target Sample Size   Total Sample Size="369"
Sample Size from India="369" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
INTRODUCTION

HNC is the malignancy of head and neck region including oral cavity, nasopharynx, oropharynx,
hypopharynx and also larynx .The main risk for these types of cancer include tobacco, alcohol use,
HPV(Human Papilloma-virus) and the use of Pan Masala.Management for HNC include
chemotherapy, radiotherapy, immuno-therapy and surgery.Cancer patients are more susceptible to
infections than normal people as the cancer therapy reduces the immunity to fight infections.AMR is
when the micro-organisms develop the ability to overcome the drugs and its action to kill. Improper
prescription, poor sanitation, poor infection control in hospitals, lack of new antibiotics, incomplete
treatment and over usage of antibiotics has known to be the leading reason for AMR. So survival rate
of HNC patients is highly depended on the disease state as well as the infections persisting.

OBJECTIVES OF THE STUDY

Impact of infection on prognosis can be severe, potentially resulting in the death of patients who
could have otherwise be survived, to estimate the occurrence of infections among Head and Neck
cancer patients, to evaluate the antimicrobial prescription and resistance patterns among Head and
Neck cancer patients and to determine the survival status and cause of mortality among Head and
Neck cancer patients.

NEED FOR THE STUDY

Head and Neck cancer is one of the leading cancer among Indian populations which is generally
managed by Surgical therapy, Radiation therapy, Chemotherapy and Targeted/immunological
therapy either alone or in combinations.The disease as well as treatment of HNC/long stay
hospitalization makes patients more prone to infections.It has been reported that about 19% of HNC
patients suffers from infection. There is limited evidences on the prevalence of types of infections
and antimicrobial prescription among HNC.Thus we aim to assess the prevalence of infection,
antimicrobial prescription pattern and give insight to antimicrobial resistance among HNC. Further
we also aims to determine the survival status of HNC patients and their cause of death.

METHODOLOGY

It is a retrospective study where data of patients who is 18 years or above with advanced stage Head
and Neck Cancer undergone Chemo-radiation therapy, radiation therapy, targeted therapy or
immunological therapy in the Department of Radiation therapy and Oncology will be collected from
Medical Record Department of Justice K.S Hegde Charitable Hospital.

STATISTICAL ANALYSIS

The data will be analyzed using descriptive statistics (Mean, Standard deviations, frequency,
percentage, inter-quartile range) and inferential statistics (chi-square test, Pearson/Spearman
correlation).Data will be analyzed using log–rank and Kaplan-Meier test. Data will be analyzed by
multivariate COX proportional model and hazard ratio. P value <0.05 will be considered statistically
significant.

OUTCOME MEASURES

This study will provide a summary of Prevalence of infections, Prescription pattern of antimicrobial
agents, Prevalence of infections, Antimicrobial resistance and also the Survival status of HNC
patients.
 
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