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

Exploratory 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23819
Enrollment
40
Registered
2017-10-24
Start date
2017-10-24
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal cancer patients

Interventions

The 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

Sponsors

Nutricia Research B.V. Uppsalalaan 12 3508 CT Utrecht, the Netherlands Collaboration with University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 ¡Ý 18 years 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of ileostoma or ileal pouch 2. Malnutrition Universal Screening Tool (MUST) score of ¡Ý2, 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

Design outcomes

Primary

MeasureTime frame
To explore the compliance to nutritional test product intake

Secondary

MeasureTime frame
- 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

Contacts

Public ContactEsmee Kolthof
Esmee.kolthof@nutricia.com+31 (0)30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)