Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement (PROTEOS)
Colorectal Cancer, Lung Cancer
About this trial
This is an interventional supportive care trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1 Age ≥ 18 years Written informed consent Exclusion Criteria: Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization Received radiotherapy within 2 months prior to the study Weight loss >10% in the last 6 months Body Mass Index < 20.0 kg/m2 Life expectancy < 3 months Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice Presence of ileostoma or ileal pouch Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator Known pregnancy or lactation Current alcohol or drug abuse in the opinion of the investigator Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Sites / Locations
- UZ Gent
- AZ Nikolaas
- North Estonia Medical Centre
- Tartu University Hospital
- National Cancer Institute
- Amphia Ziekenhuis
- Maastricht University Medical Center
- St. Antonius Hospital
- Máxima Medisch Centrum
- Zaans Medisch Centrum
- Oslo University Hospital
- Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
- Hospital of Szczecin
- Centro Hospitalar Universitario Lisboa Norte EPE
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Test group
Control group
125 mL Fortimel/Nutridrink Compact Protein