RecruitingNot ApplicableNCT07365072

The PRIMROSE Trial

A Randomised Controlled Trial to Evaluate the Impact of Thoracic PRehabilitation With Inspiratory Muscle tRaining cOmpared to Standard prEhabilitation in People With Lung Cancer for Surgical Treatment . The PRIMROSE Trial


Sponsor

Swansea Bay University Health Board

Enrollment

100 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study (the PRIMROSE Trial) is testing whether a structured "prehabilitation" program — exercise, nutrition, and breathing training before surgery — can improve recovery outcomes for people with lung cancer who are scheduled for surgery but are currently unfit or at risk. **You may be eligible if...** - You are an adult with lung cancer and your cancer is surgically removable - You have been referred for prehab by your lung cancer medical team because of at least one of the following: breathlessness, reduced fitness, age 70+, frailty, low lung function, or being sedentary - You are scheduled for a lung surgery such as lobectomy, segmentectomy, wedge resection, or pneumonectomy **You may NOT be eligible if...** - Your lung cancer is not surgically resectable - You have conditions that would make exercise unsafe - You are not referred through your lung cancer multidisciplinary team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInspiratory muscle training (POWERBreathe)

Resistance training for inspiratory muscles prior to procedure.

OTHERStandard Prehab

Physical optimisation


Locations(1)

Swansea Bay University Health Board

Swansea, United Kingdom

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NCT07365072


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