The PRIMROSE Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSwansea Bay University Health Board

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥1 Medical Research Council (MRC) dyspnoea score

≥1 World Health Organization (WHO) performance status (PS)

Age ≥ 70 years

Frailty index >3

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory muscle training (POWERBreathe)

    Device

    Resistance training for inspiratory muscles prior to procedure.

  • Standard Prehab

    Other intervention

    Physical optimisation

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Prehab plus deviceExperimental treatment 2 interventions
Group B: PrehabActive comparator 1 intervention

Trial outcomes

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.

Time frame
On hospital discharge (assessed up to 2 months)

Secondary outcomes

1

Measure of Quality of Life

European Organisation for Research and Treatment of Cancer (EORTC) questionnaire (EOTRC QLQ-30). The scores are transformed into a 0-100 range, where 0 is the lowest possible score and 100 is the highest. A higher score indicates a better outcome for functional and global health scores. However, a higher score on the symptom sales represent a greater burden of symptoms and a worse outcome.

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

Dyspnoea Score

Medical research council (MRC) dyspnoea score. This scale is measured from 0 to 4. A higher score means worse outcomes. A lower score means better outcomes.

Time frame
At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.
3

Performance Status

World Health Organization (WHO) performance status. This assigns scores from 0 to 5. A higher score indicates worse outcomes and a lower score indicates better outcomes.

Time frame
At Prehab initial assessment, every two weeks whilst undergoing Prehab, periprocedural, at hospital discharge (assessed up to 2 months), 1 month post procedure.
4

Thoracoscore

The Thoracic Surgery Scoring System is used in thoracic procedures to estimate mortality risk. It calculates risk based on the person co-morbidities and procedure. The Thoracoscore ranges from -7.37 to 7.37. A higher score indicates a potential worse outcome/ more risk. A lower score indicates a potential better outcome/ less risk.

Time frame
At prehab initial assessment and periprocedural.

Other outcomes

Sponsors and contacts

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