Clinical trial · Interventional
Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 125 mL Fortimel/Nutridrink Compact Protein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Test group
- description
- 125 mL Fortimel/Nutridrink Compact Protein
- interventionNames
- Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein
- type
- NO_INTERVENTION
- label
- Control group
Primary outcomes (1)
- measure
- 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.
- timeFrame
- end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available