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

Protein Intake in Patients With Colorectal or Lung Cancer 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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Lung Cancer
• Intervention / Treatment: Dietary supplement: 125 mL Fortimel/Nutridrink Compact Protein

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • UZ Gent
  • Sint-Niklaas, Belgium
    • AZ Nikolaas
• Estonia
  • Tallinn, Estonia
    • North Estonia Medical Centre
  • Tartu, Estonia
    • Tartu University Hospital
• Lithuania
  • Vilnius, Lithuania
    • National Cancer Institute
• Netherlands
  • Breda, Netherlands
    • Amphia ziekenhuis
  • Maastricht, Netherlands
    • Maastricht University Medical Center
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Veldhoven, Netherlands
    • Maxima Medisch Centrum
  • Zaandam, Netherlands
    • Zaans Medisch Centrum
• Norway
  • Oslo, Norway
    • Oslo University Hospital
• Poland
  • Poznań, Poland
    • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
  • Szczecin, Poland
    • Hospital of Szczecin
• Portugal
  • Lisboa, Portugal
    • Centro Hospitalar Universitario Lisboa Norte EPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Active Comparator: Test group; 125 mL Fortimel/Nutridrink Compact Protein	Dietary supplement: 125 mL Fortimel/Nutridrink Compact Protein; 125 mL Fortimel/Nutridrink Compact Protein®* two servings per day (300 kcal, 18 g protein per serving).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.	The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.	end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake	Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake	end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Change of body weight.	change of body weight measured with weighting scale	during 12 weeks (baseline till end of intervention at week 12]

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: MPR16TA06151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No