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

Study Overview
=================
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.

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

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Immunonutrient-enriched oral nutrition supplementation
* Dietary Supplement: Standard medical nutrition therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Standard medical nutrition therapy with Immunonutrition | Dietary Supplement: Immunonutrient-enriched oral nutrition supplementation<br>* 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.<br>* Other names: Oral Impact®, Nestle;|
| Active Comparator: Control<br>Standard medical nutrition therapy | Dietary Supplement: Standard medical nutrition therapy<br>* Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kilograms) | Changes in body weight during study period | Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | Changes in handgrip strength during study period | Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunonutrition, arginine, omega 3 fatty acid, radiotherapy, cancer treatment, head and neck cancer