NCT05526040

Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study

Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (HNC) patients during cancer treatment.

Detailed description

The study population will be adult HNC patients receiving radiotherapy and chemotherapy treatment. The targeted number of subjects is 116 patients (58 subjects in each arm). Participants will be randomly assigned to receive standard medical nutrition therapy (individualized dietary assessment and counselling, and standard nutrition supplementation as necessary) or standard medical nutrition therapy with high energy, high protein, immunonutrient-enriched oral nutrition supplementation. Immunonutrition supplementation will begin 1 week prior to cancer treatment and continued throughout the cancer treatment, and to be taken in 3 servings/day. The study involves interviewing of subjects for dietary and nutrition assessment; measurement of weight, body composition, handgrip strength; and data collection from subjects' medical records.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Immunonutrient-enriched oral nutrition supplementation	Individualized dietary assessment and counselling with additional high energy, high protein, immunonutrient-enriched oral nutrition supplement; taken 3 servings per day, from 1 week prior to cancer treatment and continued throughout the cancer treatment. Oral Impact® is an oral nutrition supplement product enriched with arginine (3.3g/sachet), omega-3 fatty acids (0.8g/sachet) and nucleotides (0.3g/sachet). The immunonutrient-enriched formula is also a complete and balanced formula, and is gluten free. The osmolality of the formula is 620 mOsm/kg water.
DIETARY_SUPPLEMENT	Standard medical nutrition therapy	Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2022-09-02
• Last updated: 2022-09-02

Locations

2 sites across 1 country: Malaysia