Clinical trial NCT05526040: Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study
Official title: Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: immunonutrition
arginine
omega 3 fatty acid
radiotherapy
cancer treatment
head and neck cancer
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight (kilograms)
timeFrame: Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment
measure: Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
measure: Nutrition status - 3-Minute Nutrition Screening (3-minNS) tool
timeFrame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Secondary outcomes:
measure: Handgrip strength
timeFrame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
measure: Functional status - Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
name: Hazreen Abdul Majid, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
name: Sing Ean Tan
role: PRINCIPAL_INVESTIGATOR
References: