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

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer
• Interventions: Dietary Supplement: Immunonutrient-enriched oral nutrition supplementation; Dietary Supplement: Standard medical nutrition therapy

• Registration Number: NCT05526040
• Lead Sponsor: University of Malaya

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02
• Study Start: 2022-11-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Written informed consent obtained
• Adult HNC patients, male or female, above 18 years of age
• Primary HNC diagnosis, stage I to III; including: cancer of the nasopharynx, oropharynx, oral cavity, hypopharynx, or larynx, etc.
• Referred and planned for curative-intent cancer treatment (radiotherapy and chemotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status < 2

Exclusion Criteria

• Inability or unwillingness to provide written informed consent or comply with the requirements of the protocol
• Patients with metastatic stage or recurring/relapse of cancer at same site
• Planned for palliative cancer treatment
• Underlying severe hepatic failure or renal dysfunction (eGFR < 30ml/min/1.73m2)
• Underlying severe sepsis, neutropenia, immune-deficiencies or autoimmune diseases
• Consumption of supplements or enriched foods containing immunonutrients (omega- 3, arginine or nucleotides) in the previous month prior to study; including dietary supplements such as: fish oil capsules, arginine tablets/powder, RNA capsules, etc.
• Known allergy or intolerance to components of the immunonutrition supplement (cow's milk, fish or soy)
• Enrolment in other cancer treatment trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Immunonutrient-enriched oral nutrition supplementation	Standard medical nutrition therapy with Immunonutrition
Control	Standard medical nutrition therapy	Standard medical nutrition therapy

Primary Outcome Measures

Name	Time	Method
Body weight (kilograms)	Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment	Changes in body weight during study period
Nutrition status - 3-Minute Nutrition Screening (3-minNS) tool	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment	Changes in nutrition status during study period (score of 3 to 4 indicates risk of moderate malnutrition, and score of 5 to 9 indicates risk of severe malnutrition)
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment	Changes in nutrition status during study period (3 categories: A- well nourished, B- moderately or suspected of being malnourished, and C- severely malnourished)

Secondary Outcome Measures

Name	Time	Method
Handgrip strength	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment	Changes in handgrip strength during study period
Functional status - Eastern Cooperative Oncology Group (ECOG) Performance Status Score	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment	Changes in functional status during study period (score of 0 to 4; whereby 0- fully active and able to carry out all activities without any restrictions, and 4- completely disabled, unable to carry on any selfcare and confined to bed or chair)

Trial Locations

Locations (2)

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

University of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia