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

Not Applicable

Completed

• Conditions: Malignant Neoplasm; Esophagitis; Mucositis
• Interventions: Dietary Supplement: Nutritional Supplementation; Other: Questionnaire Administration

• Registration Number: NCT03228147
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Study Start: 2017-07-25
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (nutrition supplement)	Questionnaire Administration	Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.
Supportive Care (nutrition supplement)	Nutritional Supplementation	Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States