Prehab plus inspiratory muscle training before lung cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.