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Fatigue after prophylactic cranial irradiation in small cell lung cancer patients


- candidate number15589
- NTR NumberNTR4218
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2013
- Secondary IDsMETC 13-4-074 
- Public TitleFatigue after prophylactic cranial irradiation in small cell lung cancer patients
- Scientific TitleFatigue after prophylactic cranial irradiation in small cell lung cancer patients
- ACRONYMN/A
- hypothesisFatigue will be at its worst 2 to 3 weeks after prophylactic cranial irradiation (PCI)
- Healt Condition(s) or Problem(s) studiedFatigue, Small cell lung cancer (SCLC), Prophylactic cranial irradiation
- Inclusion criteria-Age >=18 years
-SCLC, pathology proven
-Completed initial treatment, with at least stable disease
-WHO PS 2
-Ability to understand written questionnaires
-Written informed consent
- Exclusion criteria
- clinically relevant anemia (defined as Hb < 6 mmol/l)
- chronic renal failure (defined as MDRD-eGFR < 45 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2013
- planned closingdate1-okt-2014
- Target number of participants10
- Interventionsquestionnaires:
regarding fatigue: VAS and MVI-20 regarding quality of life: EORTCc30 and EuroQol 5D
- Primary outcomeOnset and level of fatigue after PCI measured by VAS
- Secondary outcomeOnset and level of fatigue after PCI measured by additional questionnaire: MVI-20
Changes in quality of life (Qol) after PCI: EORTC c30 and EuroQol-5D
- Timepointsfirst questionnaires to be completed in week before PCI, the first month after PCI the questionnaires have to be completed every week, the next two months the questionnaires have to be completed every two weeks
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L. Hendriks
- CONTACT for SCIENTIFIC QUERIES L. Hendriks
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryCancer related fatigue (CRF) is a common problem in oncological patients. 50-90% of oncological patients experience fatigue, the highest percentage is found in patients treated with chemo- and/or radiotherapy. CRF is one of the most important complaints related to cancer and its treatment. It is also a strong and independent predictor of quality of life (QoL) and patient satisfaction. After PCI, SCLC patients experience significantly more fatigue than patients who have not had PCI. Duration of fatigue after PCI is approximately 3 months, but no data exist regarding onset and peak of fatigue complaints after PCI. To plan starting time and duration of fatigue-modifying treatment, we want to evaluate in this study onset, peak and duration of fatigue after PCI (only in SCLC stage I-III) by VAS and other questionnaires
- Main changes (audit trail)
- RECORD21-okt-2013 - 2-dec-2013


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