Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study (HaNIS)

University of Malaya

Status: Not yet enrolling

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: Standard medical nutrition therapy; Dietary Supplement: Immunonutrient-enriched oral nutrition supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05526040

HaNIS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Intervention

Experimental group

Description:

Standard medical nutrition therapy with Immunonutrition

Treatment:

Dietary Supplement: Immunonutrient-enriched oral nutrition supplementation

Control

Active Comparator group

Description:

Standard medical nutrition therapy

Treatment:

Dietary Supplement: Standard medical nutrition therapy