Protein intake in patients with colorectal or lungcancer when receiving a nutritional supplement

Protein intake in patients with colorectal or lungcancer during first line treatment with chemo (radio) - or immunotherapy when receiving a low volume, energy dense and high protein oral nutritional supplement: a randomized, controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27071

Enrollment

126

Registered

2018-10-02

Start date

2018-10-01

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

Colorectal and lungcancer

Interventions

Duration of intervention: approximately 13 weeks Intervention group: receiving two units of test product per day for oral intake for a period of approximately 13 weeks. Control group: receiving sta

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV 2. Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks 3. Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1 4. Age ¡Ý 18 years 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ¡Ü4 days after randomization 2. Received >10 doses of radiotherapy within 2 months prior to the study 3. Weight loss >10% in the last 6 months 4. Body Mass Index < 20.0 kg/m2 5. Life expectancy < 3 months 6. Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital¡¯s standard practice 7. Presence of ileostoma or ileal pouch 8. Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator 9. Known pregnancy or lactation 10. Current alcohol or drug abuse in the opinion of the investigator 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Design outcomes

Primary

Measure	Time frame
To assess protein intake at the end of the first treatment cycle	—

Secondary

Measure	Time frame
- Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake - Body weight	—

Contacts

Public Contactcorine vlot

Nutricia

corine.vlot@danone.com+31650292055

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)