FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070556 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A cross-sectional study to examine the number of cases of obstructive sleep apnea in patients with head and neck cancer undergoing chemotherapy and radiation therapy. 
Scientific Title of Study   Prevalence of obstructive sleep apnea in head and cancer population undergoing chemoradiation therapy : A cross -sectional 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  Aishwarya I 
Designation  MPT STUDENT  
Affiliation  FATHER MULLERS MEDICAL COLLEGE AND HOSPITAL 
Address  Father Muller Medical College Father Muller Road, Kankanady, Mangalore - 575 002, Karnataka, INDIA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9739546997  
Fax    
Email  aishwaryailangovan23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms. Cherishma D sliva  
Designation  Professor of physiotherapy in cardio vascular & pulmonary science  
Affiliation  FATHER MULLERS MEDICAL COLLEGE AND HOSPITAL 
Address  Father Muller Medical College Father Muller Road, Kankanady, Mangalore - 575 002, Karnataka, INDIA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9663558311  
Fax    
Email  cheri8585@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Aishwarya I 
Designation  MPT STUDENT  
Affiliation  FATHER MULLERS MEDICAL COLLEGE AND HOSPITAL 
Address  Father Muller Medical College Father Muller Road, Kankanady, Mangalore - 575 002, Karnataka, INDIA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9739546997  
Fax    
Email  aishwaryailangovan23@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College Father Muller Road, Kankanady, Mangalore - 575 002, Karnataka, INDIA 
 
Primary Sponsor  
Name  AISHWARYA I  
Address  Father Muller Medical College Father Muller Road, Kankanady, Mangalore - 575 002, Karnataka, INDIA Dakshina Kannada KARNATAKA 575002 India 
Type of Sponsor  Other [self ] 
 
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 
AISHWARYA  FATHER MULLERS HOSPITAL   Y ward, Department of oncology Kankanady , Manglore 575002.
Dakshina Kannada
KARNATAKA 		 9739546997

aishwaryailangovan23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C080||Malignant neoplasm of submandibular gland, (3) ICD-10 Condition: C07||Malignant neoplasm of parotid gland, (4) ICD-10 Condition: C081||Malignant neoplasm of sublingual gland, (5) ICD-10 Condition: C09||Malignant neoplasm of tonsil, (6) ICD-10 Condition: C11||Malignant neoplasm of nasopharynx, (7) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (8) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (9) ICD-10 Condition: C00||Malignant neoplasm of lip, (10) ICD-10 Condition: C03||Malignant neoplasm of gum, (11) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (12) ICD-10 Condition: C05||Malignant neoplasm of palate, (13) ICD-10 Condition: C10||Malignant neoplasm of oropharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   No intervention is given to the patient  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with head and neck cancer stage III A to IV B various sites undergoing chemo/radiation therapy.

Age ≥ 18 years

Both genders 
 
ExclusionCriteria 
Details  Patients with pre-existing sleep disorders, psychiatric conditions affecting sleep.

Patient who is unable to follow the questionnaire 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To to assess the prevalence of obstructive sleep apnea in head and neck cancer   1st week of chemoradiation therapy  
 
Secondary Outcome  
Outcome  TimePoints 
Nil   Nil  
 
Target Sample Size   Total Sample Size="202"
Sample Size from India="202" 
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)   31/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/07/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aishwaryailangovan23@gmail.com].

  6. For how long will this data be available start date provided 23-12-2025 and end date provided 25-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NO
Brief Summary
Modification(s)  		 Obstructive sleep apnea is a common breathing disorder characterized by partial or complete collapse of oropharyngeal tract, resulting in periodic decrease or cessation of airflow at night. This leads to hypoxia and hypercapnia, reactive respiratory effort- related arousal, elevated markers of oxidative stress and inflammation. This increases risk of cardiovascular, metabolic and neurocognitive morbidities

Head And Neck Cancer
Head and neck cancer is a general term for epithelial cancer, is a growing concern of India, with a 57.5% increase in new cases by 2040 predicted by GLOBOCAN 2020.According to recent research, undergoing treatment for cancer in head and neck region surgical and conservative may serve as a significant risk of developing OSA. Surgery in the head and neck region causes structural alteration that may have serious effect on airflow
in the upper airway. Radiation therapy causes soft tissue edema which may lead to anatomical changes in head and neck region. Identification of severity of OSA in head and neck cancer population is typically not done in Indian population. Therefore to identify prevalence of OSA in HNC population is required.

Thus the goal for this study is to identify prevalence of obstructive sleep apnea in head and neck cancer patients using STOP-BANG questionnaire and Epworth sleepiness scale.
 
Close