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

Rutgers The State University of New Jersey

Status: Completed

Conditions: Esophagitis; Malignant Neoplasm; Mucositis

Treatments: Dietary Supplement: Nutritional Supplementation; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03228147

NCI-2017-01151 (Registry Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

071701 (Other Identifier)

Pro20170000485

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Supportive Care (nutrition supplement)

Experimental group

Description:

Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.

Treatment:

Dietary Supplement: Nutritional Supplementation

Other: Questionnaire Administration