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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Lung Cancer

Intervention / Treatment
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* Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group<br>125 mL Fortimel/Nutridrink Compact Protein | Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein<br>* 125 mL Fortimel/Nutridrink Compact Protein®* two servings per day (300 kcal, 18 g protein per serving).<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Change of body weight. | change of body weight measured with weighting scale | during 12 weeks (baseline till end of intervention at week 12] |