Clinical trial · Interventional
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
NCT00730808CI-TRIAL-00003462completedN/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)
The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.
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 |
|---|---|---|---|
| Rectal Tumors | Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PreOP Booster (food for special medical purposes) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test
- description
- Oral nutritional supplement: assignment according to consecutive random numbers.
- interventionNames
- Dietary Supplement: PreOP Booster (food for special medical purposes)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Assignment according to consecutive random numbers.
- interventionNames
- Dietary Supplement: PreOP Booster (food for special medical purposes)
Primary outcomes (3)
- measure
- Immunoinflammatory parameters
- timeFrame
- on day -2, -1, 1, 2, 3, 5, and 7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR) * preoperative radiotherapy (5x5 Gy) or chemoradiation * loop ileostoma or colostoma; Exclusion Criteria: * severe malnutrition * severe renal insufficiency * diabetes mellitus I or II * concomitant thyroid medication * corticosteroids * diuretic medication and antihypertensive medication * known or suspected allergy to any component of the investigational product(s)
References
Publications (0)
Data not yet available
No reference posted for this study.