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

Prince of Songkla University

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis

Treatments: Dietary Supplement: Oral Impact®

Study type: Interventional

Funder types: Other

Identifiers

NCT05101889

REC.56-036-13-1-1

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Immunonutrition

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oral Impact®

Control

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Oral Impact®