NCT03334071: EMBRACE

Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients

Status unknown NA Last updated 8 July 2019

What this trial tests

NA trial testing Exercise in Non Small Cell Lung Cancer in 100 participants. Status unknown.

Timeline

4 April 2014

Primary endpoint
30 December 2019

30 December 2019

Quick facts

Lead sponsor	University Hospital Southampton NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	4 April 2014
Primary completion	30 December 2019
Estimated completion	30 December 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Exercise

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Non Small Cell Lung Cancer Stage IIIB — all drugs for Non Small Cell Lung Cancer Stage IIIB →
• Non Small Cell Lung Cancer Metastatic — all drugs for Non Small Cell Lung Cancer Metastatic →

Sponsor

University Hospital Southampton NHS Foundation Trust

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer or Non Small Cell Lung Cancer Stage IIIB. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical Activity and Exercise in Lung Cancer Care: Will Promises Be Fulfilled?
   Avancini A, Sartori G, Gkountakos A, Casali M, et al · · 2020 · cited 120× · PMID 32162811 · DOI 10.1634/theoncologist.2019-0463
2. Exercise training for advanced lung cancer.
   Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, et al · · 2019 · cited 82× · PMID 30741408 · DOI 10.1002/14651858.cd012685.pub2
3. Preventive Cardio-Oncology: The Time Has Come.
   Brown SA. · · 2019 · cited 35× · PMID 31998754 · DOI 10.3389/fcvm.2019.00187