PROTEOS: Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Test group 125 mL Fortimel/Nutridrink Compact Protein |
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).
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No Intervention: Control group
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Outcome Measures
Primary Outcome Measures
- 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)]
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 Outcome Measures
- 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)]
Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
- Change of body weight. [during 12 weeks (baseline till end of intervention at week 12]]
change of body weight measured with weighting scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
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Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
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Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
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Age ≥ 18 years
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Written informed consent
Exclusion Criteria:
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Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
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Received radiotherapy within 2 months prior to the study
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Weight loss >10% in the last 6 months
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Body Mass Index < 20.0 kg/m2
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Life expectancy < 3 months
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Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice
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Presence of ileostoma or ileal pouch
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Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator
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Known pregnancy or lactation
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Current alcohol or drug abuse in the opinion of the investigator
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Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
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Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UZ Gent | Gent | Belgium | ||
2 | AZ Nikolaas | Sint-Niklaas | Belgium | ||
3 | North Estonia Medical Centre | Tallinn | Estonia | ||
4 | Tartu University Hospital | Tartu | Estonia | ||
5 | National Cancer Institute | Vilnius | Lithuania | ||
6 | Amphia Ziekenhuis | Breda | Netherlands | ||
7 | Maastricht University Medical Center | Maastricht | Netherlands | ||
8 | St. Antonius Hospital | Nieuwegein | Netherlands | ||
9 | Máxima Medisch Centrum | Veldhoven | Netherlands | ||
10 | Zaans Medisch Centrum | Zaandam | Netherlands | ||
11 | Oslo University Hospital | Oslo | Norway | ||
12 | Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu | Poznań | Poland | ||
13 | Hospital of Szczecin | Szczecin | Poland | ||
14 | Centro Hospitalar Universitario Lisboa Norte EPE | Lisboa | Portugal |
Sponsors and Collaborators
- Nutricia Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MPR16TA06151