Status:
UNKNOWN
Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Conditions:
Non Small Cell Lung Cancer
Non Small Cell Lung Cancer Stage IIIB
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Trial Phase: Pilot Indication: Stage IIIB/IV NSCLC Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy. Secondary Objective: 1) To asse...
Detailed Description
EMBRACE is a multi-centre pilot study for 100 patients with EGFR negative NSCLC undergoing first line platinum based chemotherapy. It is a prospective randomised (1:1) 2-arm controlled study. A nested...
Eligibility Criteria
Inclusion
- Male or female patients, aged over 18 years old
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- Stage IIIb/IV disease
- Patients being treated with first line gemcitabine and platinum based chemotherapy (other equivalent regimens may be considered on discussion with Judith Cave)
- Performance status 0-2 (PS 2 have to be deemed fit enough to complete all cycles of chemotherapy).
Exclusion
- Unable to consent
- Under 18 years
- Unable to perform CPET
- Significant cardiac ischaemia of \> 1.5mm symptomatic and \> 2mm asymptomatic observed on the baseline ECG
- Weight of \>145kg (weight limit for cycle ergometer)
- Any other contraindication to CPET based on ACCP/ATS Guidelines and summarised in the table below.
Key Trial Info
Start Date :
April 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03334071
Start Date
April 4 2014
End Date
December 30 2019
Last Update
July 8 2019
Active Locations (1)
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1
University Hospitals Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD