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CTRI Number  CTRI/2023/11/059856 [Registered on: 15/11/2023] Trial Registered Prospectively
Last Modified On: 04/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessing the Nutrition and swallowing in patients with upper aerodigestive tract cancers undergoing surgery or radiotherpay 
Scientific Title of Study   Nutrition and swallowing assessment and short-term outcome evaluation of pre-treatment swallowing rehabilitative counselling in upper aerodigestive tract cancer patients undergoing surgery or radiotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nivedhan R  
Designation  Senior Resident 
Affiliation  PGIMER 
Address  Department of otorhinolaryngology and head and neck surgery, PGIMER, Sector-12,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9524649590  
Fax    
Email  nivedhanmbbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sourabha K Patro  
Designation  Assistant Professor  
Affiliation  PGIMER 
Address  Department of otorhinolaryngology and head and neck surgery, PGIMER, Sector-12,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8872401912  
Fax    
Email  sourabhlipi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sourabha K Patro  
Designation  Assistant Professor  
Affiliation  PGIMER 
Address  Department of otorhinolaryngology and head and neck surgery, PGIMER, Sector-12,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8872401912  
Fax    
Email  sourabhlipi@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, Sector-12, Chandigarh, Pin-160012 
 
Primary Sponsor  
Name  Postgraduate institute of Medical Education and Research Chandigarh 
Address  Sector 12, Chandigarh. Pin-160012 
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 Nivedhan R  PGIMER  room number 4099, ENT OPD, New OPD block, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 9524649590

nivedhanmbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh, Instituitional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C131||Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, (2) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (3) ICD-10 Condition: C329||Malignant neoplasm of larynx, unspecified, (4) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL   NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult patients (>18 years) of both genders with biopsy-proven cancers of the upper aerodigestive tract who are consenting for the study.
For Group I:
1. Adult patients (>18 years) of both genders with biopsy-proven cancers of the upper aerodigestive tract who are consenting to the study and are planning to undergo upfront surgical management.
For Group II:
1. Adult patients (>18 years) of both genders with biopsy-proven cancers of the upper aerodigestive tract who are consenting to the study and are planning to undergo upfront Radiotherapy/Chemoradiotherapy
 
 
ExclusionCriteria 
Details  1. Endocrine and salivary gland malignancies of the head and neck not involving the upper aerodigestive tract.
2. Second primary malignancies.
3. Recurrent disease/Relapse
4. Uncontrolled co-morbidities limiting the primary management of the disease.
5. Non-consenting individuals
6. Patients with a history of prior surgical procedures of the upper aerodigestive tract for any benign or non-tumorous conditions which can impact swallowing and nutritional status of the patient.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pre and post-treatment nutritional status in patients of upper aerodigestive tract cancers to understand the impact of treatment on nutrition.
2. Status of swallowing and associated patient-related outcome measures both pre and post-treatment in patients of upper aerodigestive tract cancers.
3. Speech intelligibility in patients of oral cavity cancers.
 		 1. Pre-intervention: the patients will be evaluated before 2 weeks of the definitive intervention.
2. After the definitive treatment they will undergo post-operative nutritional assessment, swallowing assessment and instrumental assessment with FEES, and speech assessment and swallowing rehabilitation at 6 weeks and 12 weeks. Another follow-up will be done at 24 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
• Diagnostic and therapeutic delays for patients of upper aerodigestive tract cancers
• Outcomes from post-hoc subgroup analysis of the patients including
o swallowing impairment and its possible contributing factors in correlation with pretreatment clinical, radiological and nutritional assessment findings
o Swallowing functionality and nutritional status of patients in correlation with the oncological clearance for extensive tumors (Post and superior extensions) in the surgically treated patients.
o Swallowing functionality and nutritional status of patients undergoing trans-oral robotic surgery for cancers of oropharynx and neck secondaries with unknown primary compared to cases treated by conventional surgery.
 		 o There is no defined endpoint for the study, and all patients completing the follow-up protocol will be continuously followed up every 3 months till the end of the study period of the thesis.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  During the time of publication of thesis, data regarding the comparison of the results of the study will be shared.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response (Others) -  It will not be available for analysis for anyone to any purpose

  5. By what mechanism will data be made available?
    Response (Others) -  at present cannot be decided

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 31-12-2024?
    Response (Others) -  at present cannot be decided

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This observational study will be conducted at the Department of Otolaryngology and Head and Neck Surgery of the Post Graduate Institute of Medical Education and Research in Chandigarh, India, from July 2023 to December 2024; it seeks to evaluate the nutritional status, swallowing function, and the influence of pretreatment rehabilitative counselling in patients with upper aerodigestive tract cancers. With a sample size of 80 patients, divided into two groups undergoing surgery or chemo/radiotherapy, the study aims to assess primary outcomes, including nutritional status, swallowing function, and speech intelligibility, while also exploring secondary objectives such as diagnostic and therapeutic delays, posthoc subgroup analyses, and continuous follow-up for up to 24 weeks or beyond. This research aims to provide insights into the challenges faced by these patients and the potential benefits of pretreatment counselling in their overall well-being. 
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