Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients

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 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).

Conditions

• Non Small Cell Lung Cancer
• Non Small Cell Lung Cancer Stage IIIB
• Non Small Cell Lung Cancer Metastatic

Interventions

BEHAVIORAL

Exercise

High intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. The supervised in-hospital exercise training sessions will last \<1 hour, exercise training intensities will be individually tailored to each CPET. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high intensity (50%Δ) for a predetermined amount of time. The home-based training programme will involve stair climbing (where possible) and brisk walking to achieve heart rates commensurate with those achieved during the in-hospital exercise training sessions.

Sponsors & Collaborators

• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Sandy Jack, PhD · University Hospitals Southampton NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-04

Primary Completion

2019-12-30

Completion

2019-12-30

Countries

• United Kingdom

Study Locations