The PRIMROSE Trial

Swansea Bay University Health Board

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07365072

PRIMROSE

Details and patient eligibility

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.

Full description

To compare inspiratory muscle training (IMT) with standard Prehabilitation (Prehab) to Prehab alone, in people with lung cancer for surgical procedure.

One hundred and thirty-four participants will be recruited for the study (67 for each arm) and with an anticipated attrition rate of 20-25%, one hundred participants will finally be studied.

All adults with lung cancer, aged18 years or over, diagnosed or suspected of non-small cell lung cancer (NSCLC) with surgically resectable disease, who are referred for pre-treatment optimization with Prehab from the lung cancer Multi-Disciplinary Teams (MDTs).

Adults with lung cancer are referred for pre-treatment optimization with Prehab if they meet the following referral criteria: ≥1 Medical Research Council (MRC) dyspnoea score; or ≥1 World Health Organization (WHO) performance status (PS); age ≥ 70 years or frailty index >3; borderline or poor pulmonary function (forced expiratory volume in one second (FEV1) or diffusion capacity for carbon monoxide (DLCO) <50%); sedentary people despite having adequate FEV1 or DLCO. People will be included in the trial if they are capable of giving consent to participation and aged 18 and over.

Additionally, people who have no contraindications to IMT use.

The aim is to evaluate the impact of thoracic Prehab with IMT compared to standard Prehab in reducing post procedural pulmonary complications following surgical resection in people with lung cancer in a randomised control trial.

Descriptive statistics will be used to summarise participants' characteristics and outcome measures. Statistical analyses will be performed using SPSS statistical software, version 20.0 (IBM Corporation, Armonk, NY, USA). Two-sided significance tests will be used (a\0.05). Data will be presented as mean and standard deviation (SD), or median and interquartile range (IQR) for variables with a skewed distribution. Differences between groups in categorical variables will be tested with Chi square or Fisher's exact test. For continuous data the student's t test or the Mann-Whitney U test will be used. The Wilcoxon signed rank test will be used to compare MIP and QoL at T0 and T1 and T2. Relative risk will be calculated for post procedural pulmonary complications (PPCs) graded 1-V using the Clavien Dindo classification and impact of IMT on the study group compared to the control group. Assuming a 36.7 incidence of PPC after the procedure in the control arm and using a significance level of 0.05 and a power of 80%, 50 participants are required in each arm.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Prehab plus device

Experimental group

Description:

Standard Prehab plus inspiratory muscle training device

Treatment:

Other: Standard Prehab

Device: Inspiratory muscle training (POWERBreathe)

Prehab

Active Comparator group

Description:

Standard Prehab

Treatment:

Other: Standard Prehab