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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post procedure complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Prehab plus device
Standard Prehab plus inspiratory muscle training device
干预措施: Standard Prehab (Other)
Prehab
Standard Prehab
干预措施: Standard Prehab (Other)
Prehab plus device
Standard Prehab plus inspiratory muscle training device
干预措施: Inspiratory muscle training (POWERBreathe) (Device)
结局指标
主要结局
Post procedure complications
时间窗: On hospital discharge (assessed up to 2 months)
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.
次要结局
- 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.)
- Levels of activity(On Prehab initial assessment, every two weeks of Prehab, periprocedural, at hospital discharge (assessed up to 2 months) and 1 month post procedure.)
- Maximum Inspiratory Pressure (MIP)(At Prehab initial assessment, periprocedural and at hospital discharge (assessed up to 2 months).)
- Forced expiratory volume in 1 second (FEV1)(At Prehab initial assessment)
- Transfer factor for carbon monoxide (TLCO)(At Prehab initial assessment)
- Mortality(At hospital discharge (assessed up to 2 months), 1 month post procedure , 3 months post procedure and 1 year post procedure)
- Length of hospital admission(On hospital discharge (assessed up to 2 months).)