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Onderzoek naar (signaalstoffen van) de voedingstoestand bij patienten met een tumor in de long, borst, prostaat of dikke darm.


- candidate number10417
- NTR NumberNTR3094
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-okt-2011
- Secondary IDsNL 37535.029.11 CCMO
- Public TitleOnderzoek naar (signaalstoffen van) de voedingstoestand bij patienten met een tumor in de long, borst, prostaat of dikke darm.
- Scientific TitlePrevalence and biomarkers of precachexia in patients with advanced cancer scheduled for treatment with chemotherapy.
- ACRONYM
- hypothesisCachexia is a frequently observed syndrome in cancer patients. It reversely impacts quality of life and is linearly and prognostically related to clinical outcome but cannot be fully reversed by conventional nutritional therapy. In contrast to cachexia, pre-cachexia is expected to be a still reversible state that may respond to nutritional intervention. Recently, an expert-opinion of pre-cachexia has been put forward that can be used for the early identification, and subsequently for the early treatment, of pre-cachexia. The current proposal aims to study the prevalence of pre-cachexia and cachexia, to identify patient groups at increased risk and to explore potential biomarkers of pre-cachexia.
- Healt Condition(s) or Problem(s) studiedCancer, Cachexia, Precachexia
- Inclusion criteria4.2.1 Inclusion criteria for cohort (part 1, not-WMO):
1. Adults (> 18 years);
2. Advanced breast cancer, colorectal cancer, hormone refractory prostate cancer or stage III/IV non small cell lung cancer;
3. Treatment plan: Palliative chemotherapy or in the case of stage III NSCLC: chemoradiation.
- Exclusion criteria1. Ascites (for which treatment is necessary) or serious pitting edema;
2. Chemotherapy treatment in the past month;
3. Not able to speak the Dutch language;
4. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2011
- planned closingdate1-mei-2013
- Target number of participants400
- InterventionsTwo interviews of at maximum 30 minutes (with one week in between), including 3 small self-administered questionnaires, 2 VAS-scales and a measurement of body composition. In addition, 60 patients with stage III/IV non-small cell lung cancer are asked for extra blood collection during (two tubes) routinely collected blood in fasted state to identify potential biomarkers of pre-cachexia and cachexia.
- Primary outcomeTo determine the prevalence of (pre)cachexia (based on the current definition) in patients with advanced cancer scheduled for treatment with chemotherapy.
- Secondary outcome1. To determine the prevalence of pre-cachexia and cachexia related to the type of tumour (part 1, not-WMO);
2. To determine the reproducibility and validity of the measurement of pre-cachexia and cachexia at two consecutive time points (at minimum one week apart from each other) in one patient (part 1, not-WMO);
3. To determine whether potential biomarkers of pre-cachexia can be identified in a subgroup of cancer patients with stage III/IV non-small cell lung cancer (part 2, WMO).
- TimepointsCross-sectional design (try for 2 measurements with one week in between).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.A.E. Bokhorst - de van der Schueren, van
- CONTACT for SCIENTIFIC QUERIES M.A.E. Bokhorst - de van der Schueren, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra
- PublicationsN/A
- Brief summaryCachexia is a frequently observed syndrome in cancer patients. It reversely impacts quality of life and is linearly and prognostically related to clinical outcome but cannot be fully reversed by conventional nutritional therapy. In contrast to cachexia, pre-cachexia is expected to be a still reversible state that may respond to nutritional intervention. Recently, an expert-opinion of pre-cachexia has been put forward that can be used for the early identification, and subsequently for the early treatment, of pre-cachexia. The current proposal aims to study the prevalence of pre-cachexia and cachexia, to identify patient groups at increased risk and to explore potential biomarkers of pre-cachexia.
- Main changes (audit trail)
- RECORD6-okt-2011 - 18-okt-2011


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