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CTRI Number  CTRI/2024/11/077350 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On: 19/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Neck pain in head and neck cancer patients 
Scientific Title of Study   Evaluation of Neck Pain and Related Issues in Head and Neck Cancer Patients Receiving Anti-cancer Treatment: A Follow-Up 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  Abhishek Daf 
Designation  Post Graduate Student  
Affiliation  Department of Oncology Physiotherapy, KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD Number 39, Room Number 29, Nehru Nagar, Belgaum- 590010, Karnataka, India.

Belgaum
KARNATAKA
590010
India 
Phone  8999485908  
Fax    
Email  daaffabhishek@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nikita Pawar 
Designation  Assistant professor 
Affiliation  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, Belgaum, Karnataka. 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD Number 39, Room Number 29, Nehru Nagar, Belgaum, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9731012979  
Fax    
Email  nikitapawar@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Nikita Pawar 
Designation  Assistant professor 
Affiliation  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, Belgaum, Karnataka. 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD Number 39, Room Number 29, Nehru Nagar, Belgaum, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9731012979  
Fax    
Email  nikitapawar@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research, Belgaum-590010, Karnataka, India 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research 
Address  KAHER Institute of Physiotherapy, Department of Oncology Physiotherapy, OPD Number 39, Room Number 29, Nehru Nagar, Belgaum, Karnataka. 
Type of Sponsor  Private medical college 
 
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 Nikita Pawar  KLEs Dr Prabhakar Kore Hospital and Medical Research Center  KAHER Institute Of Physiotherapy, Department of Oncology Physiotherapy, OPD Number 39, Room Number 29, Belgaum, Karnataka.
Belgaum
KARNATAKA 		 9731012979

nikitapawar@klelipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Diagnosed head and neck cancer patients
2. Both male and female patients above 18 years of age.
3. Patients undergoing surgery for head and neck cancer
4. Patients undergoing radiation therapy or chemotherapy.
 
 
ExclusionCriteria 
Details  1. Patients not willing to participate
2. Metastasis to other sites
3. Diagnosis other than head and neck cancer
4.cognitive impairment, or psychiatric disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Neck pain  baseline, 1st month, 2nd month, and 3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
neck disability, anxiety and depression, quality of life  baseline, 1st month, 2nd month, and 3rd month 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/11/2025 
Date of Study Completion (India) 10/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Aim: To assess neck pain and related concerns in head and neck cancer patients receiving anti-cancer treatment.

Research question: What is the severity of neck pain and related concerns and how does it vary during anti-cancer treatment among head and neck cancer (HNC) patients?

Inclusion criteria: 1. Diagnosed head and neck cancer patients 2.Both male and female patients above 18 years of age 3.Patients undergoing surgery for head and neck cancer 4. Patients undergoing radiation therapy or chemotherapy.

Exclusion criteria: 1. Patients not willing to participate 2.Metastasis to other sites 3. Diagnosis other than head and neck cancer. 4. Cognitive impairment or psychiatric disorders.

A written informed consent for participation in the study will be obtained from all the patients. All the willing patients will be screened for inclusion and exclusion criteria. Patients meeting the eligibility criteria will undergo baseline evaluation using PAIN-DETECT, FACT-H&N, Neck Disability Index, and HADS 2 to 3 days before the initiation of treatment for cancer. Then the regular follow-up assessments will be conducted at predefined intervals at the end of 1st month, 2nd month, and 3rd month. After the collection of data statistical analysis will be done.

 

 
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