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

Sponsor
Nutricia Research (Industry)
Overall Status
Completed
CT.gov ID
NCT05677958
Collaborator
(none)
126
14
2
35
9
0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Test group: receiving daily 2 servings of a low volume, energy dense and high protein oral nutritional supplement (ONS) Control group: not receiving any study product. These subjects will be receiving standard of care.Test group: receiving daily 2 servings of a low volume, energy dense and high protein oral nutritional supplement (ONS) Control group: not receiving any study product. These subjects will be receiving standard of care.
Masking:
None (Open Label)
Masking Description:
randomised controlled, open label, parallel-group, multi-centre and multicountry study
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Jan 17, 2019
Actual Primary Completion Date :
Dec 17, 2021
Actual Study Completion Date :
Dec 17, 2021

Arms and Interventions

Arm Intervention/Treatment
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).

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. 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)]

    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.

Secondary Outcome Measures

  1. 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)]

    Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake

  2. Change of body weight. [during 12 weeks (baseline till end of intervention at week 12]]

    change of body weight measured with weighting scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Gent Gent Belgium
2 AZ Nikolaas Sint-Niklaas Belgium
3 North Estonia Medical Centre Tallinn Estonia
4 Tartu University Hospital Tartu Estonia
5 National Cancer Institute Vilnius Lithuania
6 Amphia Ziekenhuis Breda Netherlands
7 Maastricht University Medical Center Maastricht Netherlands
8 St. Antonius Hospital Nieuwegein Netherlands
9 Máxima Medisch Centrum Veldhoven Netherlands
10 Zaans Medisch Centrum Zaandam Netherlands
11 Oslo University Hospital Oslo Norway
12 Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu Poznań Poland
13 Hospital of Szczecin Szczecin Poland
14 Centro Hospitalar Universitario Lisboa Norte EPE Lisboa Portugal

Sponsors and Collaborators

  • Nutricia Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nutricia Research
ClinicalTrials.gov Identifier:
NCT05677958
Other Study ID Numbers:
  • MPR16TA06151
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023