Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment

Study Overview
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Brief Summary
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This pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.

Detailed Description
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PRIMARY OBJECTIVES: I. To identify two products (one from the creamy shake category and one from the tea category) with the highest total average score that will be selected to move onto further testing. OUTLINE: Patients receive 10 different nutrition supplements orally (PO) and complete questionnaires based on each sample in a single session over 60-90 minutes.

Official Title
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Sensory Evaluation of a New Oral Nutrition Supplement in Patients at Risk for Mucositis

Conditions
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Esophagitis, Malignant Neoplasm, Mucositis

Intervention / Treatment
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* Dietary Supplement: Nutritional Supplementation
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy) At risk for mucositis OR with stage I mucositis or esophagitis (i.e. radiotherapy to the head, neck, esophagus or lung OR treatment with fluorouracil (5-FU) or other chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk for xerostomia Within the first 3 weeks of initiation of a new type of therapy Able to read and write in English Able to provide written informed consent Exclusion Criteria: Food allergy to any component of the supplement Inability to taste or smell due to medication or health condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (nutrition supplement)<br>Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes. | Dietary Supplement: Nutritional Supplementation<br>* Given PO<br>* Other names: Supplementation;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A creamy shake product with the highest total average nutrition supplement scores as assessed by questionnaires | Will identify one product from the creamy shake category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale. | Up to 1 year | 
| A tea product with the highest total average nutrition supplement scores as assessed by questionnaires | Will identify one product from the tea category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (Cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale. | Up to 1 year |