Prehab plus inspiratory muscle training before lung cancer surgery
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
This trial will test whether adding inspiratory muscle training to a prehabilitation program helps people with resectable lung cancer have fewer breathing problems after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Swansea Bay University Health Board Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Swansea) |
| Trial ID | NCT07365072 on ClinicalTrials.gov |
What this trial studies
This is a randomized trial comparing standard thoracic prehabilitation (Prehab) alone versus Prehab plus inspiratory muscle training (using a POWERBreathe device) in adults with surgically resectable non-small cell lung cancer. Approximately 134 participants will be randomized 1:1, with planned follow-up to measure post-procedural pulmonary complications and functional outcomes. Eligible participants are adults referred for pre-treatment optimization because of breathlessness, reduced exercise capacity, older age, frailty, or borderline lung function. The intervention is delivered prior to surgery and outcomes will capture complication rates, exercise capacity, and readiness for safe resection.
Who should consider this trial
Good fit: Adults (age 18+) with diagnosed or suspected resectable non-small cell lung cancer who are referred for Prehab because of breathlessness, reduced performance status, age≥70, frailty, borderline pulmonary function (FEV1 or DLCO <50%), or sedentary status are ideal candidates.
Not a fit: People who are not candidates for surgery, have contraindications to inspiratory muscle training, or cannot provide informed consent are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, adding inspiratory muscle training could reduce post-operative breathing complications, improve exercise capacity, and increase the number of patients who are fit for curative surgery.
How similar studies have performed: Smaller studies in thoracic and upper abdominal surgery have suggested inspiratory muscle training can lower pulmonary complications, but larger randomized evidence specifically in lung cancer prehabilitation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adults with lung cancer with surgically resectable disease who are referred for pre-treatment optimization with Prehab, from the lung cancer Multi-Disciplinary Teams (MDTs). 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 * Frailty index \>3 * Borderline or poor pulmonary function (forced expiratory volume in one second (FEV1) \< 50% or diffusion capacity for carbon monoxide (DLCO) \<50%) * Sedentary people despite having adequate FEV1 or DLCO * People who are eligible for surgical procedures, including endobronchial excision of tumour, or lobectomy, segmental resection, pneumonectomy or wedge resection, either via a minimally invasive approach or a standard thoracotomy approach Additionally: * Participants will be included in the trial if they are capable of providing verbal and written consent for Prehab, and written consent for undergoing a surgical procedure for lung cancer * People over 18 years of age * All people will be considered regardless of their baseline respiratory muscle strength Exclusion Criteria: Inclusion criteria not met * 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 * 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
Where this trial is running
Swansea
- Swansea Bay University Health Board — Swansea, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Ira Goldsmith, Professor
- Email: Ira.Goldsmith@wales.nhs.uk
- Phone: 44 01792 704084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.