At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Inspiratory muscle training (POWERBreathe) (device), Standard Prehab (other)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- Inspiratory muscle training (POWERBreathe) — device: Resistance training for inspiratory muscles prior to procedure. · Standard Prehab — other: Physical optimisation
- Patient visit burden
- Not specified by the sponsor
In plain English
The PRIMROSE Trial is a study for adults with lung cancer that can be treated with surgery. It looks at whether breathing (inspiratory) muscle training before an operation, as part of a 'prehab' (preparation) programme, can help reduce breathing problems after surgery and shorten hospital stays. It is sponsored by Swansea Bay University Health Board.
Who can take part
- Adults over 18 with lung cancer that can be removed with surgery
- People referred for a 'Prehab' programme before treatment by their lung cancer team
- Referred for at least one of these reasons: breathlessness score of 1 or more, performance status of 1 or more, age 70 or over, frailty score above 3, weaker than usual lung function, or being inactive despite reasonable lung function
- Eligible for lung surgery such as removing part or all of a lung, using keyhole or open surgery
- Able to give verbal and written consent for Prehab and written consent for lung cancer surgery
- Anyone may take part regardless of their starting breathing muscle strength
Who may not be able to
- People with certain other cancers or non-cancerous conditions, such as cancer that has spread, mesothelioma, sarcoma, tumours in the chest area, or benign (non-cancerous) disease
- People who decline or do not attend Prehab, or who do not consent to surgery
- People with high heart risk who are waiting for tests or treatment (such as unstable angina or fainting)
- People with another serious condition that could make Prehab unsafe
- People with a hernia in the tummy or recent tummy surgery
- People who have had a collapsed lung for no clear reason, or large air pockets (bullae) seen on scans
- People who cannot understand written or spoken English without a carer to translate
- People with a burst (perforated) ear drum
- People whose heart failure gets worse after breathing muscle training
- People with high blood pressure in the lungs (pulmonary hypertension)
- People who have had, or are likely to get, painful inflammation of the rib cartilage (costochondritis)
- People who have taken part in a similar study that could bias the results
What taking part involves
- • A Prehab programme including inspiratory muscle training (breathing muscle exercises) before lung cancer surgery
- • Lung cancer surgery to remove the tumour, which may be keyhole or open surgery
Time commitment: Not stated — ask the trial team about the number of visits, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 100
- Started
- 2025-05-01
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for cancer
- • NA - 100 participants
- • Smoking is a major cause for developing lung cancer
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with cancer
Where?
- • Swansea - Swansea Bay University Health Board
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
To compare inspiratory muscle training (IMT) with standard Prehabilitation (Prehab) to Prehab alone, in people with lung cancer for surgical procedure. One hundred and thirty-four participants will be recruited for the study (67 for each arm) and with an anticipated attrition rate of 20-25%, one hundred participants will finally be studied. All adults with lung cancer, aged18 years or over, diagnosed or suspected of non-small cell lung cancer (NSCLC) with surgically resectable disease, who are referred for pre-treatment optimization with Prehab from the lung cancer Multi-Disciplinary Teams (MDTs). Adults with lung cancer are referred for pre-treatment optimization with Prehab if they meet the following referral criteria: ≥1 Medical Research Council (MRC) dyspnoea score; or ≥1 World Health Organization (WHO) performance status (PS); age ≥ 70 years or frailty index \>3; borderline or poor pulmonary function (forced expiratory volume in one second (FEV1) or diffusion capacity for carbon monoxide (DLCO) \<50%); sedentary people despite having adequate FEV1 or DLCO. People will be included in the trial if they are capable of giving consent to participation and aged 18 and over. Additionally, people who have no contraindications to IMT use. The aim is to evaluate the impact of thoracic Prehab with IMT compared to standard Prehab in reducing post procedural pulmonary complications following surgical resection in people with lung cancer in a randomised control trial. Descriptive statistics will be used to summarise participants' characteristics and outcome measures. Statistical analyses will be performed using SPSS statistical software, version 20.0 (IBM Corporation, Armonk, NY, USA). Two-sided significance tests will be used (a\\0.05). Data will be presented as mean and standard deviation (SD), or median and interquartile range (IQR) for variables with a skewed distribution. Differences between groups in categorical variables will be tested with Chi square or Fisher's exact test. For continuous data the student's t test or the Mann-Whitney U test will be used. The Wilcoxon signed rank test will be used to compare MIP and QoL at T0 and T1 and T2. Relative risk will be calculated for post procedural pulmonary complications (PPCs) graded 1-V using the Clavien Dindo classification and impact of IMT on the study group compared to the control group. Assuming a 36.7 incidence of PPC after the procedure in the control arm and using a significance level of 0.05 and a power of 80%, 50 participants are required in each arm.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adults with lung cancer with surgically resectable disease who are referred for pre-treatment optimization with...
- ✓The referral criteria for Prehab is below:
- ✓≥1 Medical Research Council (MRC) dyspnoea score
- ✓≥1 World Health Organization (WHO) performance status (PS)
- ✓Age ≥ 70 years
Who cannot take part
- ✗Inclusion criteria not met
- ✗People diagnosed with other cancers namely, that has spread lung cancer, mesothelioma, sarcoma, mediastinal tumours, or...
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
Swansea Bay University Health Board
Swansea SA6 6NL, United Kingdom
How to Get in Touch
Ira Goldsmith, Professor
Sponsor contactCONTACT
Tracy Jones, Physiotherapy
Sponsor contactCONTACT