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โ† Trials
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The PRIMROSE Trial

RecruitingNAAges 18 Years - 90 YearsAllSwansea Bay University Health Board
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In plain words

What the trial is, and whether it could suit you

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 mak

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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: * โ‰ฅ1 Medical Research Council (MRC) dyspnoea score * โ‰ฅ1 World Health Organization (WHO) performance status (PS) * Age โ‰ฅ 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
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What it tests

  • Inspiratory muscle training (POWERBreathe)
  • Standard Prehab
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Where

1 site
Swansea Bay University Health Board
Swansea, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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