Colorectal Cancer, Lung Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENT125 mL Fortimel/Nutridrink Compact Protein
125 mL Fortimel/Nutridrink Compact Protein®\* two servings per day (300 kcal, 18 g protein per serving).
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
randomised controlled, open label, parallel-group, multi-centre and multicountry study
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium, Estonia, Lithuania, Netherlands, Norway, Poland, Portugal
Outcome results
None listed