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The use of a medical nutrition supplement in patients with metastatic colorectal cancer


- candidate number28075
- NTR NumberNTR6747
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-okt-2017
- Secondary IDsMPR16TA06159 Nutricia
- Public TitleThe use of a medical nutrition supplement in patients with metastatic colorectal cancer
- Scientific TitleExploratory intervention study: the use of a medical nutrition supplement in patients with metastatic colorectal cancer receiving first line of capecitabine, oxaliplatin and bevacizumab (CAPOX-B) treatment
- ACRONYMNUTRACT
- hypothesis
- Healt Condition(s) or Problem(s) studiedColorectal metastised cancer, Nutrition supplement
- Inclusion criteria1. Histologically proven colorectal cancer
2. Presence of distant metastases
3. Eligible and scheduled for first line treatment with CAPOX-B systemic treatment
4. Performance status (WHO/ECOG) of 0 or 1
5. Age 18 years
6. Written informed consent
- Exclusion criteria1. Presence of ileostoma or ileal pouch
2. Malnutrition Universal Screening Tool (MUST) score of 2, indicating high risk of malnutrition
3. Body mass index < 20.0 kg/m2
4. Known intolerance or allergy to dairy, fish, or other ingredients of the test product
5. Known pregnancy or lactation
6. Current alcohol, drug or medication abuse in opinion of the investigator
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-okt-2017
- planned closingdate30-sep-2019
- Target number of participants40
- InterventionsThe test group will be asked to take the medical nutrition supplement twice per day, during the first 3 cycles of CAPOX-B treatment. The control group receives the same medical treatment with CAPOX-B and standard of care.
- Primary outcomeTo explore the compliance to nutritional test product intake
- Secondary outcome- Tolerance and safety
- Systemic treatment related parameters
- Body weight and body composition
- Quality of life and health status
- Dietary intake
- Physical activity
- Fatigue
- Blood chemistry
- TimepointsV0 (Screening), V1 (Week 0, Randomisation), V2 (Week 1, Start 1st treatment cycle), V3 (Week 4, 1 to 4 days prior to start 2nd treatment cycle), V4 (Week 4, start 2nd treatment cycle), V5 (Week 7, start 3rd treatment cycle), V6 (Week 9, prior to Visit 7), V7 (Week 10, End of treatment), Follow-up telephone call within 1 week after V7.
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Esmee Kolthof
- CONTACT for SCIENTIFIC QUERIESMSc Anke Bongers
- Sponsor/Initiator Nutricia Research BV, University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Specialized Nutrition as part of the Utrecht Centre for Food and Health
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-okt-2017 - 16-nov-2017


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