Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jie Deng (ucla)
Headshot of Jie Deng
Jie Deng

Description

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

Details

Keywords

Locally Advanced Head and Neck Carcinoma, Head and Neck Neoplasms, Dietary Supplement, Quality-of-Life Assessment

Eligibility

Location

  • University of California at Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Jie Deng (ucla)
    Assistant Professor-in-residence, Radiation Oncology, Medicine. Authored (or co-authored) 20 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT05115760
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated