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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228147
• Other study ID #: 071701
• Secondary ID: NCI-2017-01151Pr
• Status: Completed
• Phase: N/A
• First received: July 18, 2017
• Last updated: November 15, 2017
• Start date: July 25, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis
• Malignant Neoplasm
• Mucositis
• Neoplasms

Intervention

Dietary Supplement:
• Nutritional Supplementation
Given PO

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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