search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Feeding strategy during mucositis


- candidate number21689
- NTR NumberNTR5070
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2015
- Secondary IDsMETc 2014/423 
- Public TitleFeeding strategy during mucositis
- Scientific TitleFeeding strategy in pediatric cancer patients with gastro-intestinal mucositis: a multicenter prospective observational study
- ACRONYMMucoNut
- hypothesisWhat is the current feeding strategy in pediatric cancer patients suffering from chemotherapy induced mucositis?
- Healt Condition(s) or Problem(s) studiedChildren, Cancer, Mucositis, Nutrition
- Inclusion criteriaChildren (0-18 yrs of age) admitted to the University Medical Center Groningen (UMCG) or Academic Medical Center (AMC) Amsterdam, for treatment of B Non Hodgkin lymphoma (B-NHL), or autologous stem cell transplantation(SCT)
- Exclusion criteria-
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate6-mei-2016
- Target number of participants15
- Interventions-
- Primary outcomeFeeding strategy (tube feeding, tpn) and duration in days
- Secondary outcome- Severity of mucositis measured by plasma citrulline (during regular vena punctures, no extra punctures will be done for study purpose only, the remaining plasma will be used to measure citrulline)
- Number of days of mucositis >grade 1, and the peak severity of mucositis according to the NCI-CTCAE criteria
- Weight, daily
- Number of days with pain and the peak level of pain, daily measured with the VAS/Faces score
- Days of analgesics, and the total amount of analgesics
- The number of infectious complications and number of positive blood cultures
- Length of hospital stay
- Timepoints- after chemotherapy course: daily
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. W.J.E. Tissing
- CONTACT for SCIENTIFIC QUERIESMD. PhD. W.J.E. Tissing
- Sponsor/Initiator University Medical Center Groningen (UMCG), Beatrix Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summarySince there are no data on children with mucositis, and because of the inconsistency in the available literature and clinical practice, we set up this research project to study which strategy is currently used in the clinical practice in pediatric cancer patients with chemotherapy induced mucositis, how many times a switch to parenteral nutrition is inevitable, and what the consequences of feeding strategies are on clinical outcomes. In a multicenter prospective observational study, children (0-18 yrs of age) admitted to the UMCG or AMC, for treatment of B-NHL, or autologous SCT will be included. Feeding strategy (own intake, tube feeding, tpn) and duration in days will be the main outcome.
- Main changes (audit trail)
- RECORD17-feb-2015 - 20-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl