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

Primary Purpose

Colorectal Cancer, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
125 mL Fortimel/Nutridrink Compact Protein
Sponsored by
Nutricia Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Arm Type

Active Comparator

No Intervention

Arm Label

Test group

Control group

Arm Description

125 mL Fortimel/Nutridrink Compact Protein

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Change of body weight.
change of body weight measured with weighting scale

Full Information

First Posted
November 23, 2022
Last Updated
January 9, 2023
Sponsor
Nutricia Research
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1. Study Identification

Unique Protocol Identification Number
NCT05677958
Brief Title
Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement
Acronym
PROTEOS
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
randomised controlled, open label, parallel-group, multi-centre and multicountry study
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Active Comparator
Arm Description
125 mL Fortimel/Nutridrink Compact Protein
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
125 mL Fortimel/Nutridrink Compact Protein
Intervention Description
125 mL Fortimel/Nutridrink Compact Protein®* two servings per day (300 kcal, 18 g protein per serving).
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Secondary Outcome Measure Information:
Title
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Description
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
Time Frame
end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
Title
Change of body weight.
Description
change of body weight measured with weighting scale
Time Frame
during 12 weeks (baseline till end of intervention at week 12]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
North Estonia Medical Centre
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Facility Name
National Cancer Institute
City
Vilnius
Country
Lithuania
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Máxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Facility Name
Zaans Medisch Centrum
City
Zaandam
Country
Netherlands
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
City
Poznań
Country
Poland
Facility Name
Hospital of Szczecin
City
Szczecin
Country
Poland
Facility Name
Centro Hospitalar Universitario Lisboa Norte EPE
City
Lisboa
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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

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