Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation
- Conditions
- Oral Mucositis
- Interventions
- Dietary Supplement: Oral Impact®
- Registration Number
- NCT05101889
- Lead Sponsor
- Prince of Songkla University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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
- receipt of curative surgery for HNC
- allergies to any component of the immunonutrition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immunonutrition Oral Impact® 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. Control Oral Impact® 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.
- Primary Outcome Measures
Name Time Method Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria 6 weeks after initiation of concurrent chemoradiation (CCRT) Proportion of severe oral mucositis between two groups
- Secondary Outcome Measures
Name Time Method Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria through study completion, an average of 6 weeks Proportion of patients with other treatment-related toxicities between two groups
C-reactive protein (CRP) in milligrams per liter (mg/L) 6 weeks after initiation of CCRT and 1 month after CCRT completion mean CRP between two groups
progression-free survival (PFS) at 3 years compare PFS between two groups
body weight in kilograms 6 weeks after initiation of CCRT and 1 month after CCRT completion mean changes of body weight between two groups
serum albumin in grams per deciliter (g/dL) 6 weeks after initiation of CCRT and 1 month after CCRT completion mean serum albumin between two groups
hemoglobin in grams per deciliter (g/dL) 6 weeks after initiation of CCRT and 1 month after CCRT completion mean hemoglobin between two groups
neutrophil-to-lymphocyte ratio (NLR) 6 weeks after initiation of CCRT and 1 month after CCRT completion mean NLR between two groups
actual dose of radiation in centigrays (cGy) through study completion, an average of 6 weeks mean actual dose of radiation between two groups
cumulative dose of cisplatin in milligrams per square meter (mg/m2) through study completion, an average of 6 weeks mean cumulative dose of cisplatin between two groups
platelet-to-lymphocyte ratio (PLR) 6 weeks after initiation of CCRT and 1 month after CCRT completion mean PLR between two groups
overall survival (OS) at 3 years compare OS between two groups