Measuring the patients ability to exercise capacity after Radiotherapy

Recruiting

Conditions: Respiratory disorders in diseasesclassified elsewhere,

Registration Number: CTRI/2022/08/045087

Lead Sponsor: MAHE Manipal

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. Patientsâ€™ 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 understandingof the radiation effects on the heart and the lung on eventual functionaloutcomes in physical effort tolerance of the patients. It will also help inrecognizing the patients who might be more vulnerable to development ofmanifest cardiopulmonary toxicity.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 121

Inclusion Criteria

Patients being planned for definitive or adjuvant thoracic radiotherapy that involves direct radiation exposure to at least a part of heart and lungs.
Good performance score (KPS â‰¥70), and ability to perform the physical tests required for assessment.
Adequate baseline hematocrit, and cardiac and pulmonary function.
Estimated life expectancy of at least 12 months.
Willing to participate in the study, and provides voluntary informed consent.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Correlation between lung and heart dose exposure and fall in effort tolerance:	4years
a. Correlation coefficient.	4years
b. Regression graph.	4years
c. 6-minute walk distance.	4years

Secondary Outcome Measures

Name	Time	Method
2.Effect of thoracic radiotherapy on effort tolerance	4years

Trial Locations

Locations (1): Kasturba Medical College MAHE Manipal
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College MAHE Manipal
🇮🇳Udupi, KARNATAKA, India
jyothi
Principal investigator
9481375737
jyothi.nagesh@manipal.edu