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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
Intervention / Comparator Agent
|
|
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.
|