BridgeMD
New treatment option for Cancer
Official title The PRIMROSE Trial
ClinicalTrials.gov ID: NCT07365072
What this study is testing
- What it's testing
- Smoking is a major cause for developing lung cancer. People diagnosed with lung cancer, may be offered surgery which offers a complete cure.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Adults with lung cancer with surgically resectable disease who are referred for pre-treatment optimization with Prehab, from the lung cancer...
- ≥1 Medical Research Council (MRC) dyspnoea score
- ≥1 World Health Organization (WHO) performance status (PS)
- Age ≥ 70 years
- Frailty index \>3
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Swansea, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Swansea, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.