Skip to content

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?

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?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29029
Enrollment
46
Registered
2014-10-06
Start date
2015-02-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatigue, prophylactic cranial irradiation, small cell lung cancer, MRI vermoeidheid, profylactische schedelbestraling, kleincellig longcarcinoom, MRI

Interventions

MRI will be performed approximately one week before PCI and two weeks after PCI. Blood samples will be drawn on the same day as the MRI. Fatigue and quality of life will be measured with questionnair

Sponsors

AzM PO Box 5800 6202 AZ Maastricht The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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 18 years - stage I-III NSCLC pathology proven - Completed treatment with chemoradiotherapy, with at least SD - WHO PS 18 years - WHO PS < 2 - Ability to understand written questionnaires - Written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Changes in white matter integrity and bold response after PCI. Differences between SCLC patients and controls for change in white matter integrity and bold response.

Secondary

MeasureTime frame
- Relationship between changes in MRI parameters and changes in MVI-20, EORTC c30, EuroQol-5D , HADS and CFQ - Relationship between changes in MRI parameters and changes in IL-6, TNF¦Á, CRP and leukocytes/differential - To evaluate whether there are differences on MRI findings/laboratory findings / questionnaires between SCLC patients treated with PCI, NSCLC patients and healthy controls

Contacts

Public ContactL. Hendriks

Dept of Pulmonary Diseases, MUMC+ PO Box 5800

lizza.hendriks@mumc.nl+31 (0) 43 387 6543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)