NCT04575831: ENPAL

Exercise, Nutrition, and Palliative Care in Advanced Lung Cancer (ENPAL)

Completed NA Last updated 3 December 2020

What this trial tests

NA trial testing Exercise, Nutrition, and Palliative Symptom Management in Advanced Lung Cancer in 10 participants. Completed in 30 April 2020.

Timeline

1 September 2019

Primary endpoint
30 April 2020

30 April 2020

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	1 September 2019
Primary completion	30 April 2020
Estimated completion	30 April 2020
Sites	1 location across Canada

Drugs / interventions tested

• Exercise, Nutrition, and Palliative Symptom Management

Conditions studied

• Advanced Lung Cancer — all drugs for Advanced Lung Cancer →

Sponsor

University of Calgary

Who can join

Eligibility, any sex, with Advanced Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Evidence supports exercise and nutrition as beneficial for enhancing QOL in earlier stages of lung cancer; however, there is minimal research of either intervention - and none with combined interventions - in advanced lung cancer patients. In addition to a multimodal intervention approach that includes nutrition and exercise, consideration of advanced cancer care symptom management is crucial for optimizing the potential benefits of either intervention.

Objectives: Primary outcome measure of this study is feasibility, including recruitment (% who participate from those eligible), attendance (weekly group class), assessment completion, safety (adverse event reporting), attrition rates, and qualitative themes generated from one-on-one participant interviews. The secondary outcome to be measured is the impact of the intervention on PROs, including QOL, fatigue and symptom burden, as well as self-reported physical activity levels and physical function assessed in-person.

Methods: The proposed exercise intervention will include a centre-based group exercise program plus home-based exercises, and behaviour change support for advanced non-small cell lung cancer (NSCLC) patients, classified as stage III or IV with self-reported symptom burden. Eligible participants must be cleared by the health care professionals (HCP) to engage in mild to moderate levels of physical activity (PA). Using a prospective, mixed-methods design (supported by the Medical Research Council guidance for the evaluation of complex interventions), the quantitative component of this pilot study will measure feasibility and exploratory outcome measures, with an embedded qualitative component to examine participant perspectives about study tolerability/feasibility of the intervention. A subset of participants and instructors will be recruited for qualitative interviews using purposive sampling to achieve maximum variation based on factors that may lead to different viewpoints (e.g., age, gender, lung cancer type/stage, treatment).

Relevance: The proposed work will inform the design of a future pragmatic trial for this population. The goal is to build a patient-focused model of care that delivers wellness resources for advanced lung cancer care that will ultimately improve the patients' health and QOL. This approach is novel, patient-focused, and will build a tailored approach within existing resources to deliver optimal care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of a multimodal exercise, nutrition, and palliative care intervention in advanced lung cancer.
   Ester M, Culos-Reed SN, Abdul-Razzak A, Daun JT, et al · · 2021 · cited 34× · PMID 33581739 · DOI 10.1186/s12885-021-07872-y