Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement

The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.

Inclusion Criteria:Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IVEligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeksPerformance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1Age ≥ 18 yearsWritten informed consentExclusion Criteria:Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomizationReceived radiotherapy within 2 months prior to the studyWeight loss >10% in the last 6 monthsBody Mass Index < 20.0 kg/m2Life expectancy < 3 monthsPrescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practicePresence of ileostoma or ileal pouchContra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigatorKnown pregnancy or lactationCurrent alcohol or drug abuse in the opinion of the investigatorInvestigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirementsParticipation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study