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CTRI Number  CTRI/2026/01/102558 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study To Evaluate Cognitive Functions In cancer Patients With Non-Brain Cancers Receiving Chemotherapy help with fact-cog questionnaire 
Scientific Title of Study   Assessment of Cognitive Functions In Non-Central Nervous System Cancer Patients Undergoing Chemotherapy- A Coss 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  Dhruvi Manojbhai Prajapati 
Designation  1st year Post Graduate student 
Affiliation  Sumandeep Vidyapeeth 
Address  PG 1 Classroom 2nd Floor, Department Of Neurological and psychosomatic disorders, college of Physiotherapy, Deemed to be University at and post ,Pipariya ,Taluka Waghodia

Vadodara
GUJARAT
391760
India 
Phone  09714806834  
Fax    
Email  dhruviprajapati091@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhwani Chanpura  
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth 
Address  Staffroom Ground floor, Department of Neurological and psychosomatic disorders, college of Physiotherapy, Deemed to be University at and post piparia ,taluka Waghodia

Vadodara
GUJARAT
391760
India 
Phone  9974704464  
Fax    
Email  dhwani.cop@sumandeepvidyapeeth.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Dhwani Chanpura  
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth 
Address  Staffroom Ground floor, Department of Neurological and psychosomatic disorders, college of Physiotherapy, Deemed to be University at and post piparia ,taluka Waghodia

Vadodara
GUJARAT
391760
India 
Phone  9974704464  
Fax    
Email  dhwani.cop@sumandeepvidyapeeth.edu.in  
 
Source of Monetary or Material Support  
Dhiraj General Hospital ,Waghodia road, Vadodara, Gujarat, India 391760 
 
Primary Sponsor  
Name  Dhruvi Prajapati 
Address  College of Physiotherapy ,Sumandeep Vidyapeeth Deemed to be University ,Piparia, Waghodia ,Vadodara 391760 
Type of Sponsor  Other [[Self funded]] 
 
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 
Dhruvi Prajapati  Dhiraj General Hospital  Oncology Department,4th floor Dhiraj General Hospital, Waghodia road, Vadodara,Gujarat 391760
Vadodara
GUJARAT 		 9714806834

dhruviprajapati091@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth 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-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed with any non-central nervous system cancer.
Currently receiving 1st cycle of chemotherapy and onwards.
Willing to provide informed consent.
 
 
ExclusionCriteria 
Details  Previous history of neurological disorders and diagnosed with psychiatric illnesses.
Patients with uncontrolled systemic diseases.
Patients with sensory deficits.
Patient undergoing concurrent radiotherapy treatment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional Assessment of Cancer Therapy- Cognitive Functional Questionnaire  Outcome Measure will be taken at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Cancer Therapy-Cognitive Functional Questionnaire  it will be taken from baseline 
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
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)   09/02/2026 
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 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   This study aims to assess cognitive functions in non-central nervous system cancer patients receiving chemotherapy using the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire. The study will help identify chemotherapy-related cognitive changes and support early intervention to improve patient quality of life. Patients will be recruited from the oncology department. Only Eligible individuals will be screened, based on the inclusion and exclusion criteria. After explaining the study purpose and whole procedure of study, informed consent form will be given. The patient will be informed that the questionnaire assessed perceived cognitive function, not intelligence. They will be instructed to respond based on their experiences during the past 7 days. Clarification will be provided that there are no right or wrong answers. The FACT-Cog questionnaire is administered in self-reported format. If the patient has difficulty reading or understanding, the questionnaire will be interviewer-assisted, without influencing responses.  
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