Physical Functioning Throughout Lung Cancer Treatment

Lung Cancer Clinical Trial

— LUCAT  

Official title:

Physical Functioning Throughout Lung Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02493114
• Other study ID #: 1
• Status: Recruiting
• Start date: July 2015
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Hasselt University
• Contact: Chris Burtin, PhD
• Phone: 0032499387898
• Email: chris.burtin[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comorbidities		Before start of treatment
Other	Number of hospital admissions		12 months after treatment initiation
Other	All cause and cancer-related mortality		12 months after treatment initiation
Other	Symptoms (Visual analogue scales)		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
Other	Cancer-specific Quality of life (European Organization for the Research and Treatment of Cancer Questionnaire and lung cancer module - EORTC QLQ-C30-LC13)		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
Other	General Health Status (12-item Short Form Health Survey - SF-12)		Before start of treatment vs. 3 months after treatment initiation
Other	General Health Status (EuroQol 5-dimensions)		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
Other	Daily functioning (Instrumental Activities of Daily Living Scale - IADLS)		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
Other	Fatigue (Multidimensional Fatigue Inventory - MFI-20)		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
Other	Dyspnea (modified medical research council scale - MMRC)		Before start of treatment vs.3 months after treatment initiation
Other	Anxiety and depression (Hospital Anxiety and Depression Scale)		Before start of treatment vs. 3 months after treatment initiation
Other	Care needs (Care Dependency Scale)		Before start of treatment vs. 3 months after treatment initiation
Other	Dyspnea (San Diego Shortness of Breath Questionnaire (SOBQ))		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
Other	Depressive symptomatology (Center for Epidemiologic Studies Depression scale (CES-D))		Before start of treatment vs. 3 months after treatment initiation
Primary	6MWT		Before start of treatment versus 3 months after treatment initiation
Primary	1-minute sit to stand test		Before start of treatment versus 3 months after treatment initiation
Primary	SPPB		Before start of treatment versus 3 months after treatment initiation
Secondary	Handgrip strength		Before start of treatment vs. 3 months after treatment initiation
Secondary	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
Secondary	Quadriceps strength (isometric and isokinetic)		Before start of treatment vs. 3 months after treatment initiation
Secondary	Respiratory muscle strength (maximal inspiratory and expiratory pressure)		Before start of treatment vs. 3 months after treatment initiation