Esophagitis, Malignant Neoplasm, Mucositis
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTNutritional Supplementation
Given PO
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A creamy shake product with the highest total average nutrition supplement scores as assessed by questionnaires | Up to 1 year | 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. |
| A tea product with the highest total average nutrition supplement scores as assessed by questionnaires | Up to 1 year | 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. |
Countries
United States
Outcome results
None listed