Clinical trial · Interventional
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
NCT02848807CI-TRIAL-00023293unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Cachexia | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Dietary Modification | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Quality of Life | — | UNRESOLVED | — |
| Toxicity Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NUTRIDRINK Compact Protein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- NUTRIDRINK Compact Protein
- description
- NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice
- interventionNames
- Dietary Supplement: NUTRIDRINK Compact Protein
- type
- NO_INTERVENTION
- label
- without oral nutritional supplements
- description
- Dietary advice alone
Primary outcomes (1)
- measure
- Chemotherapy-related toxicity during 12th week of observation
- timeFrame
- at baseline and after 12th week
- description
- graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histological confirmed diagnosis of CRC in clinical stage IV * successful qualification to chemotherapy * performance status at least 80% according to Karnofsky scale and \<2 according to WHO/ECOG scale * cancer-related asymptomatic precachexia diagnosed * absence of contraindications to oral nutrition and practicable realization of oral nutrition * absence of severe, decompensated concomitant diseases * signed informed consent for the participation in the study Exclusion Criteria: * diagnosis of a malignant neoplasm in clinical stage I-III * disqualification from oncologic treatment * cancer cachexia or cancer anorexia-cachexia syndrome * poor performance status * contraindications to oral nutrition or to high protein nutrition * regular nutritional support at the moment of qualification to the study * patient incompliance at the moment of qualification to the study
References
Publications (1)
- DERIVEDZietarska M, Malgorzewicz S. Quality of Life of Colorectal Cancer Patients Treated with Chemotherapy. Nutrients. 2026 Jan 7;18(2):191. doi: 10.3390/nu18020191. PMID 41599804