Clinical trial · Interventional
Individualization of Nutritive Sensory Support Of Radiation Therapy
Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy
- 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)
Nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. Nutritional support for patients is a prerequisite for the successful management of cancer patients. Sensory changes can be side effects of chemotherapy or ionizing radiation, which damages sensory receptors in the area of radiation, disrupts the function of the salivary glands, leading to hyposalivation and a decrease in taste. Individual choice of nutrition based on sensory sensations can significantly improve the quality of life of patients and ensure timely correction of their eating behavior.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONS without a sensor component and taste + standard diet | Dietary Supplement | — | UNRESOLVED |
| Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet | Dietary Supplement | — | UNRESOLVED |
| Standard diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Test
- description
- 50 patients with squamous cell head cancer over 18 years of age, receiving chemoradiation therapy, receiving 3 bottles (х 200 ml) of ONS with Protein Oncosensation with a neutral taste throughout the course of treatment.
- interventionNames
- Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet
- type
- ACTIVE_COMPARATOR
- label
- Prospective Control group
- description
- 50 patients over 18 years of age with squamous cell carcinoma of the head and neck, receiving chemoradiation therapy, receiving standard nutritional therapy with a neutral taste throughout the course of treatment.
- interventionNames
- Dietary Supplement: ONS without a sensor component and taste + standard diet
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\> 18 years * The presence of morphological verification of squamous cell carcinoma of the head and neck * No history of anticancer treatment * ECOG score 0 - 2 * Life expectancy is more than 3 months * Normal liver, kidney and bone marrow function * Absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious diseases) * Absence of pregnancy, lactation * Initial compliance of patients (according to the consultation of a psychologist and questionnaires) with a signed informed consent Exclusion Criteria: * Simultaneous participation in another clinical trial * Failure to meet inclusion criteria * The patient's condition is ECOG ≥3, Karnovsky ≤40%. * Bleeding * Decay / Abscess in the area of tumor lesion * Pregnancy or breastfeeding * Refractory cachexia * Allergy or intolerance to any of the components of ONS
References
Publications (0)
Data not yet available