Physical Functioning Throughout Lung Cancer Treatment

Recruiting

• Conditions: Lung Cancer; Physical Activity; Exercise Capacity; Quality of Life

• Registration Number: NCT02493114
• Lead Sponsor: Hasselt University

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.

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).

Study Timeline

• Study First Submitted: 2015-06-11
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quadriceps strength (isometric and isokinetic)	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
Handgrip strength	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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium