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

Trial Title: Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study

NCT ID: NCT05526040

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Conditions: Keywords:
immunonutrition
arginine
omega 3 fatty acid
radiotherapy
cancer treatment
head and neck cancer

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Immunonutrient-enriched oral nutrition supplementation
Description: 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.
Arm group label: Intervention

Other name: Oral Impact®, Nestle

Intervention type: Dietary Supplement
Intervention name: Standard medical nutrition therapy
Description: Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
Arm group label: Control

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Kuala Lumpur

Address:
City: Kuala Lumpur
Zip: 50586
Country: Malaysia

Contact:
Last name: Sing Ean Tan
Email: tansingean@gmail.com

Investigator:
Last name: Sing Ean Tan
Email: Principal Investigator

Investigator:
Last name: Ibtisam Muhamad Nor
Email: Sub-Investigator

Facility:
Name: University of Malaya Medical Centre

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

Contact:
Last name: Hazreen Abdul Majid, Prof. Dr.

Phone: +603-7967 4757
Email: hazreen@ummc.edu.my

Investigator:
Last name: Hazreen Abdul Majid, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Nur Fadhlina Abdul Satar, Dr.
Email: Sub-Investigator

Start date: November 1, 2022

Completion date: December 31, 2023

Lead sponsor:
Agency: University of Malaya
Agency class: Other

Source: University of Malaya

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05526040