Clinical trial · Interventional
Exercise, Nutrition, and Palliative Care in Advanced Lung Cancer (ENPAL)
The Feasibility of an Exercise and Nutrition Supportive Care (Palliative) Intervention for Advanced Non-small-cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise, Nutrition, and Palliative Symptom Management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- The intervention arm will receive a 12-week multimodal intervention featuring exercise, nutrition, and palliative symptom management.
- interventionNames
- Behavioral: Exercise, Nutrition, and Palliative Symptom Management
Primary outcomes (7)
- measure
- Feasibility of recruitment: Percentage of those who participate from eligible patients approached
- timeFrame
- From 3 months pre-intervention to intervention start (week 0)
- description
- Percentage of those who participate from eligible patients approached
- measure
- Feasibility of attendance: Percentage of classes attended from those offered to participants
- timeFrame
- 0-12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Hemoglobin level of ≥80g/L as measured within 30 days of enrollment * Life expectancy \>6 months (as judged by most responsible physician) Exclusion Criteria: * Active infections at the time of enrollment * Enteral tube feeding/parenteral nutrition * Mechanical of functional bowel obstruction due to any cause * Cognitive impairment * Non-English speaking
References
Publications (1)
- DERIVEDEster M, Culos-Reed SN, Abdul-Razzak A, Daun JT, Duchek D, Francis G, Bebb G, Black J, Arlain A, Gillis C, Galloway L, Capozzi LC. Feasibility of a multimodal exercise, nutrition, and palliative care intervention in advanced lung cancer. BMC Cancer. 2021 Feb 13;21(1):159. doi: 10.1186/s12885-021-07872-y. PMID 33581739