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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05677958
Other study ID # MPR16TA06151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2019
Est. completion date December 17, 2021

Study information

Verified date January 2023
Source Nutricia Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date December 17, 2021
Est. primary completion date December 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Belgium UZ Gent Gent
Belgium AZ Nikolaas Sint-Niklaas
Estonia North Estonia Medical Centre Tallinn
Estonia Tartu University Hospital Tartu
Lithuania National Cancer Institute Vilnius
Netherlands Amphia Ziekenhuis Breda
Netherlands Maastricht University Medical Center Maastricht
Netherlands St. Antonius Hospital Nieuwegein
Netherlands Máxima Medisch Centrum Veldhoven
Netherlands Zaans Medisch Centrum Zaandam
Norway Oslo University Hospital Oslo
Poland Szpital Kliniczny im. Heliodora Swiecickiego UM w Poznaniu Poznan
Poland Hospital of Szczecin Szczecin
Portugal Centro Hospitalar Universitario Lisboa Norte EPE Lisboa

Sponsors (1)

Lead Sponsor Collaborator
Nutricia Research

Countries where clinical trial is conducted

Belgium,  Estonia,  Lithuania,  Netherlands,  Norway,  Poland,  Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary Change of body weight. change of body weight measured with weighting scale during 12 weeks (baseline till end of intervention at week 12]
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