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Completed

NCT Number: NCT02493114

Physical Functioning Throughout Lung Cancer Treatment

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.

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Key information

Conditions

Lung Cancer Behavior Exercise Capacity Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Physical Activity Quality of Life Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

About this study

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

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Acronym: LUCAT

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2015
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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