Pulmonary Rehabılıtatıon Wıth Non-Small Lung Cancer

Pulmonary Rehabılıtatıon After Chemotherapy In Patıents Wıth Non-Small Lung Cancer

The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Lung Cancer, Small Cell
• Intervention / Treatment: Other: Pulmonary Rehabilitation

Detailed Description

Patients with lung cancer often have concomitant lung and heart comorbidities that limit their cancer treatment options. For example, in the last prevalence study that included patients with newly diagnosed lung cancer, 73% of whom were men and 53% were women, there was clinically significant COPD. This patient population has shortness of breath, decreased physical capacity, low muscle condiction, and poor exercise tolerance.

Pulmonary rehabilitation is an intervention that has a scientific basis and is used systematically, aiming to optimize individual daily functions and health-related quality of life in patients with morbidity due to chronic diseases measured by clinical or physiological methods.

The effectiveness of pulmonary rehabilitation is well known in the treatment of patients with COPD and in the perioperative lung transplant preparation period. Studies lead to a significant increase in preoperative pulmonary rehabilitation exercise capacity, dyspnea and health-related quality of life.

The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.

This study was conducted with outpatients who were diagnosed with small cell lung cancer between 2021-2022, who were approved by the oncologist and physical therapist to participate in a physiotherapy and rehabilitation program. Permission for the study was obtained from the Non-Interventional Local Ethics Committee (decision dated 20.11.2018 and numbered 2018/34). The study was conducted in accordance with the Helsinki Declaration of Patient Rights. Individuals were informed about the study and a written informed consent form was signed by the individuals who volunteered to participate.

Participants Thirty patients aged 18-65 years in remission were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients with suspected pregnancy, diagnosis of diabetes mellitus, patients in metastatic period, and patients with acute/chronic infection were excluded from the study.

Evaluation The patients' age, gender, height and body weight, medical history and family history information, education status, income level, smoking (pack/year), place of residence, admission to the emergency department in the last year, number of hospital admissions and hospitalizations, and medication used The information was recorded from the patients and their files. Participation of individuals in regular physical activity was questioned. In addition, pre- and post-treatment pain was evaluated using the visual analog scale (VAS).

The evaluations applied to the patients in our study;

1. Posture Analysis
2. Normal Joint Movement and Evaluation of Muscle Shortness
3. Muscle Test
4. Six Minute Walking Test
5. Physical Activity Level
6. Dyspnea Severity
7. Quality of Life
8. Fatigue Evaluation

Applied Treatments;

1. Respiratory Exercises
2. Walking Training
3. Aerobic exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deniz Kocamaz, PhD; Phone Number: 05375735837; Email: deniz.erdankocamaz@hku.edu.tr

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Hasan Kalyoncu Univercity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Between the ages of 18-65, must be in remission.
• Surgery, adjuvant chemotherapy and radiotherapy processes must be completed.

Exclusion Criteria:

• Those with suspected pregnancy
• Diabetes mellitus diagnosis
• Patients in the metastatic period
• Patients with a diagnosis of acute/chronic infection were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary Rehabilitation; Pulmonary rehabilitation program will be applied 3 days a week at 40-60% of submaximal heart rate for a total of 8 weeks. Diaphragmatic breathing, pursed lips and segmental breathing exercises will be applied to the patients in the presence of a physiotherapist. Walking and aerobic exercise training will be given.	Other: Pulmonary Rehabilitation; 1-Pulmonary Rehabilitation: Pulmonary rehabilitation program was applied at 40-60% of submaximal heart rate, 3 days a week for a total of 8 weeks. Diaphragmatic breathing, pursed lip breathing and segmental breathing exercises were practiced with the patients in the company of a physiotherapist. Walking and aerobic exercise training was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chance from baseline in posture analysis score	Posture score is going to be assess by posture analysis form to determine change from baseline.	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	Physical Activity is going to be assess by Physical Activity Questionnaire to determine change from baseline.	8 week

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 2, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 2, 2022

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Lung Cancer; Aerobic Exercise; Pulmonary Rehabilitation; Physiotherapy and Rehabilitation; Oncological Rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 2018/09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No