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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
116
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.
Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary.
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Body weight (kilograms)
Changes in body weight during study period
Time frame: 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)
Time frame: 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)
Time frame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Handgrip strength
Changes in handgrip strength during study period
Time frame: 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)
Time frame: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
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