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RECRUITING

NCT07365072

The PRIMROSE Trial

Sponsor: Swansea Bay University Health Board

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-05-01

Completion Date

2027-05-01

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Cancer Lung Resection Inspiratory Muscle Training Prehabilitation Respiratory Complications Length of Hospital Stay

Interventions

DEVICE

Inspiratory muscle training (POWERBreathe)

Resistance training for inspiratory muscles prior to procedure.

OTHER

Standard Prehab

Physical optimisation

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

Locations (1)

Swansea Bay University Health Board

Swansea, United Kingdom