Clinical trial NCT02493114: Physical Functioning Throughout Lung Cancer Treatment
Official title: Physical Functioning Throughout Lung Cancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Exercise Capacity
Physical Activity
Quality of Life
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

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