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

NCT05677958 | Completed

• 1 other identifier: MPR16TA06151
• Study Type: interventional
• Target: 126
• Locations: 7 countries
• Sites: 14

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.

Conditions

Colorectal Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (2)

• 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.

  during 12 weeks (baseline till end of intervention at week 12]

Study Arms (2)

Test group

ACTIVE COMPARATOR

125 mL Fortimel/Nutridrink Compact Protein

Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein

Control group

NO INTERVENTION

Interventions

125 mL Fortimel/Nutridrink Compact Protein DIETARY_SUPPLEMENT

125 mL Fortimel/Nutridrink Compact Protein®\* two servings per day (300 kcal, 18 g protein per serving).

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (14)

UZ Gent

Ghent, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

North Estonia Medical Centre

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

National Cancer Institute

Vilnius, Lithuania

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Máxima Medisch Centrum

Veldhoven, Netherlands

Location

Zaans Medisch Centrum

Zaandam, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

Poznan, Poland

Location

Hospital of Szczecin

Szczecin, Poland

Location

Centro Hospitalar Universitario Lisboa Norte EPE

Lisbon, Portugal

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomised controlled, open label, parallel-group, multi-centre and multicountry study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: January 10, 2023
• Study Start: January 17, 2019
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); NL (5); PT (1); PL (2); ES (2); LI (1); BE (2)