Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients

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).

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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 Criteria:

* 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.