Clinical trial NCT05101889: Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation
Official title: Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: head and neck cancer
nasopharyngeal cancer
immunonutrition
concurrent chemoradiation
survival
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: phase II randomized, double-blind study
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria
timeFrame: 6 weeks after initiation of concurrent chemoradiation (CCRT)
Secondary outcomes:
measure: Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria
timeFrame: through study completion, an average of 6 weeks
measure: body weight in kilograms
timeFrame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
measure: serum albumin in grams per deciliter (g/dL)
timeFrame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
measure: hemoglobin in grams per deciliter (g/dL)
timeFrame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
measure: C-reactive protein (CRP) in milligrams per liter (mg/L)
timeFrame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
measure: neutrophil-to-lymphocyte ratio (NLR)
timeFrame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
measure: platelet-to-lymphocyte ratio (PLR)
timeFrame: 6 weeks after initiation of CCRT and 1 month after CCRT completion
measure: actual dose of radiation in centigrays (cGy)
timeFrame: through study completion, an average of 6 weeks
measure: cumulative dose of cisplatin in milligrams per square meter (mg/m2)
timeFrame: through study completion, an average of 6 weeks
measure: progression-free survival (PFS)
timeFrame: at 3 years
measure: overall survival (OS)
timeFrame: at 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.