Clinical trial · Interventional
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study
- 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)
This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.
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 |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Impact® | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunonutrition
- description
- Oral immunomodulating formula (Oral Impact®, Nestle) One sachet of Oral Impact® consisted of 74 g of powder providing 303 kilocalories. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session.
- interventionNames
- Dietary Supplement: Oral Impact®
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- An isocaloric isonitrogenous standard enteral nutrition formula. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session.
- interventionNames
- Dietary Supplement: Oral Impact®
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age of 18-65 years * histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010) * receipt of definitive CCRT * Eastern Cooperative Oncology Group performance status of 0-1 * creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula * absence of mucositis * able to tolerate oral feeding Exclusion Criteria: * receipt of curative surgery for HNC * allergies to any component of the immunonutrition
References
Publications (1)
- DERIVEDDechaphunkul T, Arundon T, Raungkhajon P, Jiratrachu R, Geater SL, Dechaphunkul A. Benefits of immunonutrition in patients with head and neck cancer receiving chemoradiation: A phase II randomized, double-blind study. Clin Nutr. 2022 Feb;41(2):433-440. doi: 10.1016/j.clnu.2021.12.035. Epub 2021 Dec 28. PMID 35007812