Clinical trial · Interventional
ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy
NCT05980624CI-TRIAL-00095485completedPhase 2ClinicalTrials.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)
The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve health state quality of life and increase chemotherapy tolerance
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral nutrition supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group A
- description
- nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
- type
- EXPERIMENTAL
- label
- Group B
- description
- nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and
- interventionNames
- Dietary Supplement: oral nutrition supplement
Primary outcomes (3)
- measure
- Body Composition
- timeFrame
- 3 month
- description
- measured by DEXA OR BIA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- GI cancer patients will be included in the study if they meet the following criteria: 1. Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment. 2. Age above 18 years old 3. Be accessible for chemotherapy treatment and follow-up 4. Availability to administer oral supplements 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 6. Life expectancy ≥3 months. 7. Written informed consent according to the local Ethics Committee requirements 8. Willing to fill Nutrition questionnaires. 9. Negative pregnancy test for pre-menopausal women before inclusion in the trial Exclusion Criteria: * The patients will be excluded from the study if they have the following criteria: 1. Known hypersensitivity reaction to the investigational compounds or incorporated substances 2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism) 3. Pregnancy or lactating 4. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent 5. Age \< 18 years 6. Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS
References
Publications (0)
Data not yet available
No reference posted for this study.