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Lung Neoplasms Carcinoma, Non-Small-Cell Lung
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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 assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a reduction in fitness.
2) To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET), of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE randomized controlled trial (RCT) with those who decline.
4)To investigate any relationship between baseline fitness and outcomes including therapy related complications, response, and survival in those patients who decline exercise training or are randomized to observation.
5) To assess the feasibility of the translation of in-hospital exercise training to home-based training during chemotherapy.
6) To document the effects of chemotherapy on cellular energetics and mitochondrial function.
Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be later reversed by training. The investigators wish to understand the mechanism of this detrimental effect, and investigate whether it can be prevented or attenuated by giving chemotherapy concurrently with exercise training.
Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies. Patients who decline randomisation will be offered enrolment into an observational arm.
Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational arm).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University Hospital Southampton NHS Foundation Trust and is in collaboration with Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust.
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