CancerPRIMROSENCT07365072
The PRIMROSE Trial
A study testing Inspiratory muscle training (POWERBreathe) and Standard Prehab in people with Cancer and Lung Resection, run by Swansea Bay University Health Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Lung Resection, Inspiratory Muscle Training
- What is being tested?
- Inspiratory muscle training (POWERBreathe) and Standard Prehab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
- People with a serious concomitant disorder that would compromise safety during Prehab
- People with an abdominal hernia or recent abdominal surgery
Show all 13Show fewer
- People with a history of spontaneous pneumothorax and/or evidence of large bullae on radiological imaging
- People with an inability to understand written and/or spoken English (only if carers are able to translate)
- People with a perforated ear drum
- People with worsening heart failure signs and symptoms after IMT
- People with pulmonary hypertension
- People who have suffered from or likely to suffer from costochondritis
- If a participant was involved in a similar study, with potential to cause bias or conflict of interest then they will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Swansea Bay University Health Board
Swansea, SA6 6NL
Tracy Jones, Physiotherapy, 01792 702222 ext. 23670, tracy.jones6@wales.nhs.uk
Tracy Jones
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Cancer, Lung Resection, Inspiratory Muscle Training, Prehabilitation, Respiratory Complications, Length of Hospital Stay
- Being tested
- Inspiratory muscle training (POWERBreathe), Standard Prehab
- Keywords
- Inspiratory muscle training, Cancer, Lung resection, Prehabilitation, Lung surgery, Randomised control trial, length of hospital stay
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (POWERBreathe)Device
Resistance training for inspiratory muscles prior to procedure.
Standard PrehabOther
Physical optimisation
| Study group | Role | What they receive |
|---|---|---|
| Prehab plus device | Experimental | Standard Prehab plus inspiratory muscle training device Receives: Device: Inspiratory muscle training (POWERBreathe); Other: Standard Prehab |
| Prehab | Active comparator | Standard Prehab Receives: Other: Standard Prehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On hospital discharge (assessed up to 2 months)
Secondary outcomes (11)
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.
Measured: At Prehab initial assessment, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure and 3 months post procedure.
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.
Measured: At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
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.
Measured: At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure.
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.
Measured: At prehab initial assessment and periprocedural.
Frailty Index
The Clinical Frailty Index is a tool used to assess a persons health status, by measuring the accumulation of health deficits. The scale is 1 to 9. A higher score indicates a greater level frailty and a lower score indicates a lower level of frailty. A higher score is associated with a worse outcome.
Measured: At Prehab assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
Levels of activity
Categorised as sedentary, lightly active, moderately active and very active.
Measured: On Prehab initial assessment, every two weeks of Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
Maximum Inspiratory Pressure (MIP)
Measure of respiratory muscle strength. The higher the number the stronger the respiratory muscles are. For healthy adults, normal ranges are 100 to 120cmH20 for men and 70 to 80 cmH20 in women.
Measured: At Prehab initial assessment, periprocedural and at hospital discharge (assessed up to 2 months).
Forced expiratory volume in 1 second (FEV1)
The amount of air a person can forcefully exhale in the first second after a deep breath. Ranges are categorized by percentage of predicted range. In normal lung function, 80% or higher is expected. In mild airflow obstruction values ranges vary between 50-79% and severe airflow obstruction ranges between 30-49% and very severe impairment below 30%.
Measured: At Prehab initial assessment
Transfer factor for carbon monoxide (TLCO)
Measures the amount of carbon monoxide (CO) transferred per minute from alveolar gas to red blood cells (RBCs). This is considered normal when 76% to 140% of the predicted value is achieved. Mild, moderate and severe ranges are for values below 76%.
Measured: At Prehab initial assessment
Mortality
Death rate
Measured: At hospital discharge (assessed up to 2 months), 1 month post procedure , 3 months post procedure and 1 year post procedure
Length of hospital admission
The numbers of days the participant spent in hospital. A lower number indicates a better outcome. A higher number indicates a worse outcome.
Measured: On hospital discharge (assessed up to 2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea Bay University Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Wakeman, Study director, Swansea Bay University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365072
- Sponsor's protocol ID
- PRIMROSE
- Acronym
- PRIMROSE
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be confidential and study results will be disseminated collectively on completion
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07365072
- Acronym / sponsor ID
- PRIMROSE / PRIMROSE
- Conditions
- Cancer, Lung Resection, Inspiratory Muscle Training, Prehabilitation, Respiratory Complications, Length of Hospital Stay
- Keywords
- Inspiratory muscle training, Cancer, Lung resection, Prehabilitation, Lung surgery, Randomised control trial, length of hospital stay
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Swansea Bay University Health BoardUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Prehab plus device | Experimental | Device: Inspiratory muscle training (POWERBreathe), Other: Standard PrehabStandard Prehab plus inspiratory muscle training device |
| Prehab | Active comparator | Other: Standard PrehabStandard Prehab |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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)
- People with a serious concomitant disorder that would compromise safety during Prehab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle training (POWERBreathe)Resistance training for inspiratory muscles prior to procedure. | Device | Prehab plus device |
| Standard PrehabPhysical optimisation | Other | Prehab, Prehab plus device |
Primary outcome
Post procedure complications
Time frame: On hospital discharge (assessed up to 2 months)
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.
11 secondary outcomes
Measure of Quality of Life
Time frame: At Prehab initial assessment, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure and 3 months post procedure.
Dyspnoea Score
Time frame: At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
Performance Status
Time frame: At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure.
Thoracoscore
Time frame: At prehab initial assessment and periprocedural.
Frailty Index
Time frame: At Prehab assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
Levels of activity
Time frame: On Prehab initial assessment, every two weeks of Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
Maximum Inspiratory Pressure (MIP)
Time frame: At Prehab initial assessment, periprocedural and at hospital discharge (assessed up to 2 months).
Forced expiratory volume in 1 second (FEV1)
Time frame: At Prehab initial assessment
Transfer factor for carbon monoxide (TLCO)
Time frame: At Prehab initial assessment
Mortality
Time frame: At hospital discharge (assessed up to 2 months), 1 month post procedure , 3 months post procedure and 1 year post procedure
Length of hospital admission
Time frame: On hospital discharge (assessed up to 2 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Link to power breathe website - the inspiratory muscle training device to be used as part of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will be confidential and study results will be disseminated collectively on completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Wakeman study director
Swansea Bay University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (POWERBreathe) and Standard Prehab in people with Cancer and Lung Resection, run by Swansea Bay University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ira Goldsmith, Professor (44 01792 704084, Ira.Goldsmith@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post procedure complications (time frame: On hospital discharge (assessed up to 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.