Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07365072

The PRIMROSE Trial

Led by Swansea Bay University Health Board · Updated on 2026-01-30

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The PRIMROSE Trial

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with lung cancer having surgically resectable disease referred for pre-treatment optimization with Prehab from lung cancer Multi-Disciplinary Teams
  • Medical Research Council (MRC) dyspnoea score of 1 or higher
  • World Health Organization (WHO) performance status (PS) of 1 or higher
  • Age 70 years or older or frailty index greater than 3
  • Borderline or poor lung function with forced expiratory volume in one second (FEV1) less than 50% or diffusion capacity for carbon monoxide (DLCO) less than 50%
  • Sedentary individuals despite adequate FEV1 or DLCO
  • Eligible for surgical procedures including endobronchial tumor excision, lobectomy, segmental resection, pneumonectomy, or wedge resection by minimally invasive or thoracotomy approaches
  • Capable of giving verbal and written consent for Prehab and written consent for lung cancer surgery
  • Age 18 years or older
  • Considered regardless of baseline respiratory muscle strength
Not Eligible

You will not qualify if you...

  • Does not meet inclusion criteria
  • Diagnosed with other cancers such as metastatic lung cancer, mesothelioma, sarcoma, mediastinal tumors, or benign diseases
  • Declines or does not consent to Prehab or surgery
  • High cardiovascular risk awaiting investigations or interventions (including unstable angina and syncope)
  • Serious health conditions compromising safety during Prehab
  • Abdominal hernia or recent abdominal surgery
  • History of spontaneous pneumothorax or large bullae on imaging
  • Inability to understand written or spoken English (unless carers can translate)
  • Perforated ear drum
  • Worsening heart failure signs after IMT
  • Pulmonary hypertension
  • History or risk of costochondritis
  • Participation in a similar study causing potential bias or conflict of interest

AI-Screening

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Trial Site Locations

Total: 1 location

1

Swansea Bay University Health Board

Swansea, United Kingdom, SA6 6NL

Actively Recruiting

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Research Team

I

Ira Goldsmith, Professor

CONTACT

T

Tracy Jones, Physiotherapy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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