Clinical trial · Interventional
The Effect of Nutritional Counseling for Cancer Patients
Randomised Trial of the Effects of Individual Nutritional Counseling in Cancer Patients
NCT01962272CI-TRIAL-00012386completedPhase 4ClinicalTrials.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)
Background and aims: Cancer-related malnutrition is multifactorial and related to a bad prognosis. The aim of this study was to investigate the effect of intensive, individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-, gastric-, or esophageal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Forticare®. | Dietary Supplement | — | UNRESOLVED |
| Weekly nutritional counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nutritional counseling and Forticare®
- description
- Weekly nutritional counseling and Forticare®. The goal being an intake that met the protein and energy requirements according to Harris-Benedict equation multiplied with an individual activity factor (1,1-1,5) and a stress factor (1,0-1,1). Daily protein requirements were estimated to 1,5 g/kg per day. In addition to the counseling, the patients in the intervention group were offered a high-protein nutrition supplement containing n-3 fatty acids (Forticare®, Nutricia). The recommended daily dose contained 2531 kJ, 33.8 g protein and 2.2 g EPA.
- interventionNames
- Behavioral: Weekly nutritional counseling
- Dietary Supplement: Forticare®.
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- The control group was nutritionally instructed by the nurses with the possibility to call for a dietician not related to the study if needed. No fixed schemes. Apart from the nutritional element the patients had the same care and therapy, including treatment of pain and side-effects to the treatment.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult, consecutive outpatients referred for either palliative or preoperative chemotherapy and/or radiation therapy of cancers in the stomach or the pelvic area. Exclusion Criteria: * Lack of ability to understand danish language and the instructions given
References
Publications (0)
Data not yet available
No reference posted for this study.