Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation

Oral Mucositis Clinical Trial

Official title:

Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101889
• Other study ID #: REC.56-036-13-1-1
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2013
• Est. completion date: January 31, 2017

Study information

• Verified date: October 2021
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Dietary Supplement:
• Oral Impact®
3 ready-to-drink bottles/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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
Secondary	body weight in kilograms	mean changes of body weight between two groups	6 weeks after initiation of CCRT and 1 month after CCRT completion
Secondary	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
Secondary	hemoglobin in grams per deciliter (g/dL)	mean hemoglobin between two groups	6 weeks after initiation of CCRT and 1 month after CCRT completion
Secondary	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
Secondary	neutrophil-to-lymphocyte ratio (NLR)	mean NLR between two groups	6 weeks after initiation of CCRT and 1 month after CCRT completion
Secondary	platelet-to-lymphocyte ratio (PLR)	mean PLR between two groups	6 weeks after initiation of CCRT and 1 month after CCRT completion
Secondary	actual dose of radiation in centigrays (cGy)	mean actual dose of radiation between two groups	through study completion, an average of 6 weeks
Secondary	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
Secondary	progression-free survival (PFS)	compare PFS between two groups	at 3 years
Secondary	overall survival (OS)	compare OS between two groups	at 3 years