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CTRI Number  CTRI/2022/08/045087 [Registered on: 30/08/2022] Trial Registered Prospectively
Last Modified On: 09/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Measuring the patients ability to exercise capacity after Radiotherapy 
Scientific Title of Study   Assessing the impact of radiation dose exposure to lung and heart on effort tolerance 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  jyothi  
Designation  Senior Grade Lecturer 
Affiliation  Kasturba Medical College MAHE ,Manipal 
Address  Department of Radiotherapy and Oncology Kasturba Medical College MAHE ,Manipal
same as above
Udupi
KARNATAKA
576104
India 
Phone  9481375737  
Fax    
Email  jyothi.nagesh@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Sharan 
Designation  Professor and Head 
Affiliation  Kasturba Medical College MAHE ,Manipal 
Address  Department of Radiotherapy and Oncology Kasturba Medical College MAHE Manipal
same as above
Udupi
KARNATAKA
576104
India 
Phone  9448625116  
Fax    
Email  tk.sharan@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  jyothi  
Designation  Senior Grade Lecturer 
Affiliation  Kasturba Medical College MAHE ,Manipal 
Address  Department of Radiotherapy and Oncology Kasturba Medical College MAHE ,Manipal
same as above
Udupi
KARNATAKA
576104
India 
Phone  9481375737  
Fax    
Email  jyothi.nagesh@manipal.edu  
 
Source of Monetary or Material Support  
Department of Radiotherapy and Oncology at Kasturba Medical college, MAHE, Manipal 
 
Primary Sponsor  
Name  MAHE Manipal 
Address  Department of Radiotherapy and Oncology Kasturba Medical College MAHE Manipal  
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 
jyothi  Kasturba Medical College MAHE Manipal  13, Radiotherapy and Oncology, Radiotherapy
Udupi
KARNATAKA 
9481375737

jyothi.nagesh@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients being planned for definitive or adjuvant thoracic radiotherapy that involves direct radiation exposure to at least a part of heart and lungs.
2. Good performance score (KPS ≥70), and ability to perform the physical tests required for assessment.
3. Adequate baseline hematocrit, and cardiac and pulmonary function. Estimated life expectancy of at least 12 months.
4. Willing to participate in the study, and provides voluntary informed consent
 
 
ExclusionCriteria 
Details  1. KPS<70.
2. Patients being treated with extreme hypofractionated regimen, mainly SBRT.
3. Other comorbidities such as Chronic Lung disease, cardiac disease, anemia at presentation, chronic kidney disease, peripheral neuropathy, disabilities in ambulation, etc., that might interfere with the conduct of the physical assessments.
4. Baseline impairment in respiratory or cardiac function as an indirect result of the tumor; eg. Lobar/pulmonary collapse secondary to obstructing tumor, pleural or pericardial effusion, etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Correlation between lung and heart dose exposure and fall in effort tolerance:
a. Correlation coefficient.
b. Regression graph.
c. 6-minute walk distance.
 
4years 
 
Secondary Outcome  
Outcome  TimePoints 
2. Effect of thoracic radiotherapy on effort tolerance  4years 
 
Target Sample Size   Total Sample Size="121"
Sample Size from India="121" 
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)   12/09/2022 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   "none yet" 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study will be conducted on patients requiring radiotherapy to thoracic region (including lung, esophagus, and breast cancers) reporting to the department. Once the consent has been obtained, initial assessment of the patient will be done after a brief explanation of the study.

Before RT, patients will undergo tests to evaluate their baseline physical parameters: including heart rate (HR), Blood pressure (BP), Oxygen Saturation (SpO2), and dyspnea status will be recorded. For assessment of effort tolerance, 6-Minute Walk Test (6MWT) in meters and Peak Expiratory Flow Rate (PEFR) in mL/sec will be used. QLQ-C30 questionnaire will be administered the patients as a part of subjective assessment of effort tolerance and quality of life. Patients’ demographic factors (age, gender, smoking history, comorbidities, etc.) will be recorded from their medical records.Patient will receive treatment as per the standard practice specific to the cancer site. Prior to starting RT, the patients will be requested to fill-in the QoL questionnaire, and perform the 6 minute walk test, which involves them walking at regular pace in-loop around a designated flat surface for a duration of six minutes, and the distance covered during this duration will be recorded. They will also be asked to perform the PEFR test, which involves them blowing forcibly into a PEFR meter in order to determine the PEFR. The dosimetric data of the approved radiation plan will be recorded (multiple parameters) from the Treatment Planning System. The patients will receive their treatment as per the standard practice.

 

Patient will receive treatment as per the standard practice specific to the cancer site. Prior to starting RT, the patients will be requested to fill-in the QoL questionnaire, and perform the 6 minute walk test, which involves them walking at regular pace in-loop around a designated flat surface for a duration of six minutes, and the distance covered during this duration will be recorded. They will also be asked to perform the PEFR test, which involves them blowing forcibly into a PEFR meter in order to determine the PEFR. The dosimetric data of the approved radiation plan will be recorded (multiple parameters) from the Treatment Planning System. The patients will receive their treatment as per the standard practice.

 At 4 months following completion of treatment, at their routine scheduled follow-up, patients will be enquired about their subjective perception and will be requested to again fill-in the QoL questionnaire. General examination including recording of vitals will be done. The patients will then be requested to again perform 6MWT and PEFR as a part of reassessment

The current Study will help in better understanding of the radiation effects on the heart and the lung on eventual functional outcomes in physical effort tolerance of the patients. It will also help in recognizing the patients who might be more vulnerable to development of manifest cardiopulmonary toxicity.

 


 
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