NCT02493114

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

9.3 years

First QC Date

June 11, 2015

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 6MWT

    Before start of treatment versus 3 months after treatment initiation

  • 1-minute sit to stand test

    Before start of treatment versus 3 months after treatment initiation

  • SPPB

    Before start of treatment versus 3 months after treatment initiation

Secondary Outcomes (4)

  • Handgrip strength

    Before start of treatment vs. 3 months after treatment initiation

  • Daily physical activity (self-reported and accelerometer)

    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

  • Quadriceps strength (isometric and isokinetic)

    Before start of treatment vs. 3 months after treatment initiation

  • Respiratory muscle strength (maximal inspiratory and expiratory pressure)

    Before start of treatment vs. 3 months after treatment initiation

Other Outcomes (14)

  • Comorbidities

    Before start of treatment

  • Number of hospital admissions

    12 months after treatment initiation

  • All cause and cancer-related mortality

    12 months after treatment initiation

  • +11 more other outcomes

Study Arms (2)

Patients with lung cancer

No study intervention

Healthy controls

No study intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 11, 2015

First Posted

July 9, 2015

Study Start

July 1, 2015

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations