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ACTIVE NOT RECRUITING
NCT05115760
NA

Pea Protein Oral Nutrition Supplement for the Reduction of Gastrostomy Tube Placement Rate in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiation Therapy

Sponsor: Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies the effect of a plant-based oral nutrition supplement, Kate Farms Standard 1.4 and/or Standard 1.0. as a primary source of nutrition in reducing the gastrostomy tube placement rate in patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and who are undergoing chemoradiation therapy. Gastrostomy tube (G-tube) placement can be used for enteral feedings and may lead to long term side effects such as swallowing dysfunction and lead to higher rates of permanent G-tube dependence. The Kate Farms pea protein oral nutrition supplement is formulated with organic, planted-based protein for easier digestibility without artificial sweeteners or additives and without common allergens such as dairy, soy, gluten or corn. It is nutritionally complete, calorie and protein dense and available in multiple flavors that can be consumed directly or as a base for other recipes. Giving pea protein oral nutrition supplement may provide nutritional support to decrease the need for therapeutic G-tube rate during chemoradiation compared to standard supportive care.

Official title: Intervention With Pea Protein Oral Nutrition Supplement Meal Replacement to Reduce Therapeutic Gastrostomy Tube Rates in Patients With Head and Neck Cancer Undergoing Chemoradiation Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2022-04-05

Completion Date

2027-06-01

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement

Given Kate Farms pea protein oral nutrition supplement PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

University of California at Los Angeles

Los Angeles, California, United States