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Individualized nutritional counselling during chemotherapy for colorectal cancer (COLONUT)


- candidate number15605
- NTR NumberNTR4223
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2013
- Secondary IDsNL4534502913 2013/230
- Public TitleIndividualized nutritional counselling during chemotherapy for colorectal cancer (COLONUT)
- Scientific TitleThe effect of individualized NUTritional counselling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: the COLONUT study
- ACRONYMCOLONUT
- hypothesisWe hypothesize that patients in the intervention arm benefit from individualized nutritional counselling.
- Healt Condition(s) or Problem(s) studiedColorectal, Cancer
- Inclusion criteria- Age older than 18 years
- Advanced or recurrent colorectal cancer
- Scheduled for treatment with first line palliative chemotherapy
- Either CAPOX(-B) or FOLFOX(-B)
- CT scan suitable for evaluating muscle mass at L3 level
- Understanding of the Dutch language
- Able and willing to give written informed consent
- Exclusion criteria- Prior systemic treatment for metastatic disease
- Chemotherapy in the previous six months for non-metastatic disease
- WHO performance status higher than 3
- Long-term high dose of corticosteroids: longer than three weeks, more than 10 milligram prednisolon or equivalent
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate1-sep-2016
- Target number of participants110
- InterventionsPatients in the intervention-arm will receive individualized nutritional counselling by a registered dietitian during standard treatment with chemotherapy. The main goals of the nutritional intervention will be to enable every patient to achieve sufficient protein and energy intake with attention for sufficient intake of micronutrients.
- Primary outcomeChange in skeletal muscle area (cm2)between individualized nutritional counselling versus usual nutritional care during 9 weeks of palliative chemotherapy
- Secondary outcome- To compare change in total body lean body mass and segmental lean body mass (DEXA) in patients with stage IV colorectal cancer during 9 weeks of palliative chemotherapy between individualized nutritional counselling versus usual nutritional care - To compare change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of palliative chemotherapy between individualized nutritional counselling versus ususal nutritional care
- Explore treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and handgrip strength of both study arms
- To explore associations of (changes in) muscle area with (changes in) mid-upper arm muscle circumference, whole body fat free mass (BIA) and whole body lean body mass (DEXA)
- Timepoints- Date of study inclusion
- During 9 weeks of palliative chemotherapy
- During 20 weeks of palliative chemotherapy
- Trial web siteN/A
- statusplanned
- 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)
KWF Kankerbestrijding, Alpe díHuZes Foundation
- Publications
- Brief summaryThe purpose is to study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment intensity, physical functioning, quality of life and survival will be studied. We hypothesize that patients in the intervention arm benefit from individualized nutritional counseling
- Main changes (audit trail)19-feb-2017:

INCLUSION CRITERIA NEW
- Age older than 18 years
- Stage IV colorectal cancer
- Scheduled for treatment with first line chemotherapy
- Either CAPOX(-B), FOLFOX(-B) or capecitabine (-B)
- CT scan suitable for evaluating muscle mass at L3 level
- Understanding of the Dutch language
- Able and willing to give written informed consent

- EXCLUSION CRITERIA NEW
- Chemotherapy in the previous three months
- WHO performance status higher than 3
- Long-term high dose of corticosteroids: longer than three weeks, more than 10 milligram prednisolon or equivalent

- PRIMARY OUTCOME NEW
Change in skeletal muscle area (cm2)between individualized nutritional counselling versus usual nutritional care during 9 weeks of first line chemotherapy for stage IV colorectal cancer

- SECONDARY OUTCOME NEW
- To compare change in total body lean body mass and segmental lean body mass (DEXA) in patients with stage IV colorectal cancer during 9 weeks of first line chemotherapy between individualized nutritional counselling versus usual nutritional care
- To compare change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of first line chemotherapy between individualized nutritional counselling versus usual nutritional care
- Explore treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and handgrip strength of both study arms
- To explore associations of (changes in) muscle area with (changes in) mid-upper arm muscle circumference, whole body fat free mass (BIA) and whole body lean body mass (DEXA)

TIMEPOINTS NEW
- Date of study inclusion
- During 9 weeks of first line chemotherapy
- During 20 weeks of first line chemotherapy
- RECORD25-okt-2013 - 19-feb-2017


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