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CompletedNCT02493114LUCATUpdated Sep 15, 2025

Physical Functioning Throughout Lung Cancer Treatment

An observational study in Lung Cancer, Exercise Capacity and Physical Activity, sponsored by Hasselt University. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Hasselt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Sex
All
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Study summary

This trial investigates the impact of lung cancer treatment on physical status, symptoms and quality of life. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.

Read the detailed description

Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 150 patients with lung cancer who are undergoing treatment. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy and/or immunotherapy). The aims of the study are to

  1. Investigate physical status, before start of treatment in lung cancer patients in comparison with healthy controls (primary outcome).
  2. Investigate changes in physical status over the course of treatment in lung cancer patients (primary outcome).
  3. Investigate the relationship between changes in physical status with physical activity and symptoms during treatment for lung cancer (secondary outcome).
  4. Investigate the relationship between physical status after treatment for lung cancer and comorbidities, hospitalizations and cancer-related and all-cause mortality (exploratory outcome).
02

Conditions studied

  • Lung Cancer
  • Exercise Capacity
  • Physical Activity
  • Quality of Life
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 150 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Consecutive patients with a primary diagnosis of non-small-cell lung cancer who will undergo treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones) and score a maximal of 2 on the WHO performance status classification, will be eligible for inclusion.

Healthy matched volunteers will carry out the same assessments once.

Inclusion criteria

  • undergoing treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones)
  • WHO performance status of maximal 2

Exclusion criteria

Exclusion Criteria:

  • presence of other neoplasms in the last 2 years
  • bone metastasis
  • progressive neuromuscular and neurological diseases
  • unstable cardiac disease
  • pulmonary hypertension
  • interstitial lung disease
  • orthopedic conditions that significantly impair functional status
  • mental or psychiatric disorders that impair the ability to comply with study procedures.
  • a history of cerebrovascular accident with remaining functional consequences
  • a history of lung cancer
  • difficulties in understanding and speaking Dutch
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with lung cancer

    No study intervention

  • Healthy controls

    No study intervention

06

What researchers measure

Primary outcomes

  1. 6MWT

    Time frame: Before start of treatment versus 3 months after treatment initiation

  2. 1-minute sit to stand test

    Time frame: Before start of treatment versus 3 months after treatment initiation

  3. SPPB

    Time frame: Before start of treatment versus 3 months after treatment initiation

Secondary outcomes

  1. Handgrip strength

    Time frame: Before start of treatment vs. 3 months after treatment initiation

  2. Daily physical activity (self-reported and accelerometer)

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months after treatment initiation

  3. Quadriceps strength (isometric and isokinetic)

    Time frame: Before start of treatment vs. 3 months after treatment initiation

  4. Respiratory muscle strength (maximal inspiratory and expiratory pressure)

    Time frame: Before start of treatment vs. 3 months after treatment initiation

Other outcomes

  1. Comorbidities

    Time frame: Before start of treatment

  2. Number of hospital admissions

    Time frame: 12 months after treatment initiation

  3. All cause and cancer-related mortality

    Time frame: 12 months after treatment initiation

  4. Symptoms (Visual analogue scales)

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months and 1 year after treatment initiation

  5. Cancer-specific Quality of life (European Organization for the Research and Treatment of Cancer Questionnaire and lung cancer module - EORTC QLQ-C30-LC13)

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months an after treatment initiation

  6. General Health Status (12-item Short Form Health Survey - SF-12)

    Time frame: Before start of treatment vs. 3 months after treatment initiation

  7. General Health Status (EuroQol 5-dimensions)

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 and 1 year months after treatment initiation

  8. Daily functioning (Instrumental Activities of Daily Living Scale - IADLS)

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months after treatment initiation

  9. Fatigue (Multidimensional Fatigue Inventory - MFI-20)

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months and 1 year after treatment initiation

  10. Dyspnea (modified medical research council scale - MMRC)

    Time frame: Before start of treatment vs.3 months after treatment initiation

  11. Anxiety and depression (Hospital Anxiety and Depression Scale)

    Time frame: Before start of treatment vs. 3 months after treatment initiation

  12. Care needs (Care Dependency Scale)

    Time frame: Before start of treatment vs. 3 months after treatment initiation

  13. Dyspnea (San Diego Shortness of Breath Questionnaire (SOBQ))

    Time frame: Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months and 1 year after treatment initiation

  14. Depressive symptomatology (Center for Epidemiologic Studies Depression scale (CES-D))

    Time frame: Before start of treatment vs. 3 months after treatment initiation

07

Study locations

1 site
  • Ziekenhuis Oost-Limburg
    Genk, 3600, Belgium
08

References and documents

Publications

  • Quadflieg K, Arents E, Haesevoets S, Van Hulle F, Hermans F, Criel M, Daenen M, Derom E, Spruit MA, Surmont V, Stevens D, Ruttens D, Demeyer H, Burtin C. Impact of cancer treatment on physical functioning, symptoms and health-related quality of life in patients with non-small cell lung cancer: A longitudinal observational study. Respir Med. 2025 Oct;247:108283. doi: 10.1016/j.rmed.2025.108283. Epub 2025 Jul 31. PubMed 40752628 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02493114
Lead sponsor
Hasselt University
Responsible party
Chris Burtin (Dr, Hasselt University) — Principal investigator
First posted
Jul 9, 2015
Start date
Jul 2015
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Sep 15, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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