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Completed

NCT Number: NCT05677958

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

    Time frame: 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 outcomes

  1. 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)

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

  2. Change of body weight.

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

    change of body weight measured with weighting scale

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study 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

Acronym: PROTEOS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2023
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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