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

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

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.

Study Overview

• Status: Completed
• Conditions: Esophagitis; Mucositis; Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Dietary supplement: Nutritional Supplementation

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Esophageal Diseases; Neoplasms; Mucositis; Esophagitis
• Other Study ID Numbers: 071701 (Other Identifier: Rutgers Cancer Institute of New Jersey); P30CA072720 (U.S. NIH Grant/Contract); NCI-2017-01151 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); Pro20170000485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No