The PRIMROSE Trial

NCT07365072 | Recruiting DMC

• 1 other identifier: PRIMROSE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Inspiratory muscle training; Cancer; Lung resection; Prehabilitation; Lung surgery; Randomised control trial; length of hospital stay

Outcome Measures

Primary Outcomes (1)

• 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.

  On hospital discharge (assessed up to 2 months)

Secondary Outcomes (11)

• Measure of Quality of Life

  At Prehab initial assessment, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure and 3 months post procedure.

• Dyspnoea Score

  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

  At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure.

• Thoracoscore

  At prehab initial assessment and periprocedural.

• Frailty Index

  At Prehab assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.

Study Arms (2)

Prehab plus device

EXPERIMENTAL

Standard Prehab plus inspiratory muscle training device

Device: Inspiratory muscle training (POWERBreathe); Other: Standard Prehab

Prehab

ACTIVE COMPARATOR

Standard Prehab

Other: Standard Prehab

Interventions

Inspiratory muscle training (POWERBreathe) DEVICE

Resistance training for inspiratory muscles prior to procedure.

Prehab plus device

Standard Prehab OTHER

Physical optimisation

Prehab; Prehab plus device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swansea Bay University Health Board: lead

Study Sites (1)

Swansea Bay University Health Board

Swansea, SA6 6NL, United Kingdom

RECRUITING

Related Links

• Link to power breathe website - the inspiratory muscle training device to be used as part of the study

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lisa Wakeman

  Swansea Bay University Health Board

  STUDY DIRECTOR

Central Study Contacts

Ira Goldsmith, Professor

CONTACT

44 01792 704084; Ira.Goldsmith@wales.nhs.uk

Tracy Jones, Physiotherapy

CONTACT

44 01792 702222; tracy.jones6@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: January 26, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)