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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Standard medical nutrition therapy with Immunonutrition |
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| Control | Active Comparator | Standard medical nutrition therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrient-enriched oral nutrition supplementation | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hazreen Abdul Majid, Prof. Dr. | Contact | +603-79674757 | hazreen@ummc.edu.my | |
| Sing Ean Tan | Contact | tansingean@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hazreen Abdul Majid, Prof. Dr. | Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya | Principal Investigator |
| Sing Ean Tan | Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Kuala Lumpur | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Standard medical nutrition therapy | Dietary Supplement | Individualized dietary assessment and counselling and standard nutrition supplementation via oral nutrition supplementation or enteral nutrition as necessary. |
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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 |
| University of Malaya Medical Centre | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
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