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

Head and Neck Cancer Clinical Trial

— HaNIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526040
• Other study ID #: HaNIS-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: University of Malaya
• Contact: Hazreen Abdul Majid, Prof. Dr.
• Phone: +603-79674757
• Email: hazreen[@]ummc.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.
• Standard medical nutrition therapy
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.

Locations

Country	Name	City	State
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (kilograms)	Changes in body weight during study period	Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment
Primary	Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)	Changes in nutrition status during study period (3 categories: A- well nourished, B- moderately or suspected of being malnourished, and C- severely malnourished)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Primary	Nutrition status - 3-Minute Nutrition Screening (3-minNS) tool	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)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Secondary	Handgrip strength	Changes in handgrip strength during study period	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Secondary	Functional status - Eastern Cooperative Oncology Group (ECOG) Performance Status Score	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)	Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment