Fatigue after prophylactic cranial irradiation in stage I-III small cell lung cancer patients: is there a substrate on functional magnetic resonance imaging of the brain?

Completed

Conditions: kleincellig longkanker patienten die profylactische schedelbestraling krijgen
fatigue
small-cell lung cancer
10029107

Registration Number: NL-OMON41049

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

Stage I-III SCLC:
- Age >= 18 years
- stage I-III SCLC pathology proven
- Completed initial treatment with chemoradiotherapy, with at least stable disease (SD)
- WHO PS <= 2
- Ability to understand written questionnaires
- Written informed consent;Stage III NSCLC:
- Age >= 18 years
- stage I-III NSCLC pathology proven
- Completed treatment with chemoradiotherapy, with at least SD
- WHO PS <= 2
- Ability to understand written questionnaires
- Written informed consent;Healthy controls:
- Age >= 18 years
- WHO PS <= 2
- Ability to understand written questionnaires
- Written informed consent

Exclusion Criteria

- prior radiotherapy to the brain
- claustrophobia
- pregnancy
- Metal implants or other contraindication for MRI
- inability to lie supine for 30 minutes time (MRI)
- antidepressants or steroids for the last two weeks
- clinically relevant anemia (defined as Hb < 5.5 mmol/l)
- chronic renal failure (defined as MDRD-eGFR < 30 ml/min/1.73m)
- liver biochemistry abnormalities (defined as more than two times upper limit of normal)
- major psychiatric illness requiring intervention in secondary care

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in white matter integrity and bold response after PCI. Differences<br /><br>between SCLC patients and controls for change in white matter integrity and<br /><br>bold response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Relationship between changes in MRI parameters and changes in MVI-20, EORTC<br /><br>c30, EuroQol-5D , HADS and CFQ<br /><br>- Relationship between changes in MRI parameters and changes in IL-6, TNFa, CRP<br /><br>and leukocytes/differential</p><br>