About this trial
Smoking is a major cause for developing lung cancer. People diagnosed with lung cancer, may be offered surgery which offers a complete cure. Smoking also damages the lungs and compromises a person's lung function, resulting in shortness of breath. Breathlessness limits the ability to carry out daily physical activities and exercise and makes people vulnerable to developing post procedure complications and even death. Some people with surgically treatable lung cancer have a poor ability to exercise and compromised lung function and are not fit for surgery. They will instead be referred for radiation therapy, chemotherapy or palliative care. Surgery is the preferred treatment option.
The pulmonary rehabilitation program (Prehab) improves fitness levels. In addition, it improves the level of breathlessness, exercise capacity and vulnerability of people with lung cancer, with the aim of making them fit for safe surgery. By adding a breathing training device to the Prehab program, the investigators aim to further improve participants fitness for surgery, lower their risk of developing complications and the time spent in hospital after the procedure. The breathing training device is called an inspiratory muscle training device. The hand-held device helps to train and strengthen the breathing muscles, which are then able to work more effectively. After the procedure, participants may be able to breathe and exercise more easily reducing their risk of developing complications and improving outcomes.
The study will compare two groups of people with lung cancer having surgical removal of part of the lung, at a specialist hospital . One group will receive standard Prehab and inspiratory muscle training with the device prior to the procedure; patients in the second group with receive standard Prehab prior to the procedure. Participants will be followed up for twelve months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥1 Medical Research Council (MRC) dyspnoea score
≥1 World Health Organization (WHO) performance status (PS)
Age ≥ 70 years
Frailty index >3
Disqualifiers
People diagnosed with other cancers namely, metastatic lung cancer, mesothelioma, sarcoma, mediastinal tumours, or benign diseases
People who decline Prehab
People who do not consent to Prehab, and do not attend Prehab. People who do not consent to surgery
People with a high cardiovascular risk for Prehab and awaiting investigations or interventions (including unstable angina and syncope)
Trial design
Parallel
Treatments tested in this trial
Inspiratory muscle training (POWERBreathe)
DeviceResistance training for inspiratory muscles prior to procedure.
Standard Prehab
Other interventionPhysical optimisation
Treatment groups
Trial outcomes
Primary outcomes
Post procedure complications
Post procedure complications following surgical resection in people with lung cancer. This will be graded I-V using the Clavien Dindo Classification. Post procedure complications will be broadly classified as minor (grade 1) and major complications (grade 2-5 where 5 is death). The investigators want to learn from this study, whether an inspiratory muscle trainer helps reduce grade 2 post procedure complications to grade 1 or no complications, and thereby help shorten the length of stay in hospital for people undergoing lung resection surgery. Lower numbers mean a better outcome. Higher numbers mean a worse outcome.
Secondary outcomes
Measure of Quality of Life
European Organisation for Research and Treatment of Cancer (EORTC) questionnaire (EOTRC QLQ-30). The scores are transformed into a 0-100 range, where 0 is the lowest possible score and 100 is the highest. A higher score indicates a better outcome for functional and global health scores. However, a higher score on the symptom sales represent a greater burden of symptoms and a worse outcome.
Dyspnoea Score
Medical research council (MRC) dyspnoea score. This scale is measured from 0 to 4. A higher score means worse outcomes. A lower score means better outcomes.
Performance Status
World Health Organization (WHO) performance status. This assigns scores from 0 to 5. A higher score indicates worse outcomes and a lower score indicates better outcomes.
Thoracoscore
The Thoracic Surgery Scoring System is used in thoracic procedures to estimate mortality risk. It calculates risk based on the person co-morbidities and procedure. The Thoracoscore ranges from -7.37 to 7.37. A higher score indicates a potential worse outcome/ more risk. A lower score indicates a potential better outcome/ less risk.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.