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CTRI Number  CTRI/2025/02/080973 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Acceptance of Feeding Tube in Head and Neck Cancer Patients  
Scientific Title of Study   Factors affecting Nasogastric tube acceptance in newly diagnosed Head and Neck cancer patients– Single Institutional experience 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujatha Lakshminarayanan 
Designation  Assistant Professor 
Affiliation  Cancer Institute (WIA), Adyar 
Address  Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036

Chennai
TAMIL NADU
600036
India 
Phone  9500037675  
Fax    
Email  drsujatha@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sujatha Lakshminarayanan 
Designation  Assistant Professor 
Affiliation  Cancer Institute (WIA), Adyar 
Address  Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036


TAMIL NADU
600036
India 
Phone  9500037675  
Fax    
Email  drsujatha@ymail.com  
 
Details of Contact Person
Public Query
 
Name  Sujatha Lakshminarayanan 
Designation  Assistant Professor 
Affiliation  Cancer Institute (WIA), Adyar 
Address  Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036


TAMIL NADU
600036
India 
Phone  9500037675  
Fax    
Email  drsujatha@ymail.com  
 
Source of Monetary or Material Support  
Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036 
 
Primary Sponsor  
Name  Cancer Institute (WIA) 
Address  38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036 
Type of Sponsor  Research institution and hospital 
 
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 Sujatha Lakshminarayanan  Cancer Institute (WIA), Adyar  Department of Medical Gastroenterology, Dr V Shantha Wing, 4th floor, Bhagwan Adinath Diagnostic complex, Dr S Krishnamoorthi Campus, 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036
Chennai
TAMIL NADU 
9500037675

drsujatha@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Cancer Institute (WIA), Regional cancer centre, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) 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  80.00 Year(s)
Gender  Both 
Details  1. Age 18years to 80 years
2. All newly detected head and neck cancer patients with difficulty in eating
3. Patients who are willing to give consent for the study
 
 
ExclusionCriteria 
Details  1. Patients who is not willing to give consent for the study
2. Patients with contraindications for nasogastric tube placement
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the acceptance of NGT feeding in patients with newly diagnosed head and neck cancers   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To study the factors that influence NGT acceptance in newly diagnosed head & neck cancers   baseline 
 
Target Sample Size   Total Sample Size="715"
Sample Size from India="715" 
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)   03/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Head and neck cancers are increasingly prevalent, particularly in developing countries, driven largely by tobacco use and HPV infection. Oral cancers are the most common subtype in Southeast Asia. These cancers and their treatments significantly impair chewing and swallowing, often leading to malnutrition, weight loss, and fatigue, which can hinder treatment effectiveness and worsen patient outcomes. Nasogastric tubes (NGTs) are frequently required for nutritional support in these patients, but their acceptance is often challenged by psychosocial factors. Many patients resist NGT insertion due to concerns about discomfort, appearance, and perceived bodily violation. This study investigates the factors influencing NGT acceptance in newly diagnosed head and neck cancer patients. The research will explore the correlation between NGT acceptance and factors like age, disease stage, dysphagia severity, and various psychosocial aspects. Statistical analysis, including linear and logistic regression, t-tests/ANOVA, and Pearson’s correlation, will be employed to identify significant relationships. The study anticipates that patients with more advanced disease or severe dysphagia will be more likely to accept NGTs. Furthermore, it aims to identify specific psychosocial factors impacting acceptance, such as body image concerns, perceived loss of independence, and cultural beliefs surrounding illness and medical interventions. A common misconception among patients is that NGTs are only necessary in advanced stages of emaciation, hindering early intervention. By understanding the factors influencing NGT acceptance, this study aims to develop targeted strategies to improve acceptance rates and optimize nutritional support, ultimately enhancing the care and outcomes for head and neck cancer patients.

 
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