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

Nutricia

Status

Completed

Conditions

Lung Cancer

Colorectal Cancer

Treatments

Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein

Study type

Interventional

Funder types

Industry

Identifiers

NCT05677958

MPR16TA06151

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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