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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunonutrition | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Impact® | Dietary Supplement | 3 ready-to-drink bottles/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria | Proportion of severe oral mucositis between two groups | 6 weeks after initiation of concurrent chemoradiation (CCRT) |
| Measure | Description | Time Frame |
|---|---|---|
| Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria | Proportion of patients with other treatment-related toxicities between two groups | through study completion, an average of 6 weeks |
| body weight in kilograms |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35007812 | Derived | Dechaphunkul 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. |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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phase II randomized, double-blind study
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mean changes of body weight between two groups
| 6 weeks after initiation of CCRT and 1 month after CCRT completion |
| serum albumin in grams per deciliter (g/dL) | mean serum albumin between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion |
| hemoglobin in grams per deciliter (g/dL) | mean hemoglobin between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion |
| C-reactive protein (CRP) in milligrams per liter (mg/L) | mean CRP between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion |
| neutrophil-to-lymphocyte ratio (NLR) | mean NLR between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion |
| platelet-to-lymphocyte ratio (PLR) | mean PLR between two groups | 6 weeks after initiation of CCRT and 1 month after CCRT completion |
| actual dose of radiation in centigrays (cGy) | mean actual dose of radiation between two groups | through study completion, an average of 6 weeks |
| cumulative dose of cisplatin in milligrams per square meter (mg/m2) | mean cumulative dose of cisplatin between two groups | through study completion, an average of 6 weeks |
| progression-free survival (PFS) | compare PFS between two groups | at 3 years |
| overall survival (OS) | compare OS between two groups | at 3 years |
| D010610 |
| Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |