Oral Mucositis
Conditions
Keywords
head and neck cancer, nasopharyngeal cancer, immunonutrition, concurrent chemoradiation, survival
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.
Interventions
DIETARY_SUPPLEMENTOral Impact®
3 ready-to-drink bottles/day
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
phase II randomized, double-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| hemoglobin in grams per deciliter (g/dL) | 6 weeks after initiation of CCRT and 1 month after CCRT completion | mean hemoglobin 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 |
| 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 |
| neutrophil-to-lymphocyte ratio (NLR) | 6 weeks after initiation of CCRT and 1 month after CCRT completion | mean NLR 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 |
| 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 |
| progression-free survival (PFS) | at 3 years | compare PFS between two groups |
| overall survival (OS) | at 3 years | compare OS 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 |
Outcome results
None listed