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

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677958
• Other study ID #: MPR16TA06151
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Lung Cancer
• Lung Neoplasms

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]