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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

About

Brief 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.

Primary Purpose
Supportive Care
Study Type
Interventional
Phase
Pilot/Feasibility

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Documented locally advanced head and neck malignancies for which concurrent chemoradiation has been recommended for definitive or adjuvant treatment
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) >= 2
  • Body mass index > 18kg/m^2
  • No evidence of distant metastatic disease (M1 disease)
  • No G-tube placement prior to initiation of chemoradiation
  • Eligible to undergo concurrent chemotherapy as determined by treating oncologist
  • If a woman is of childbearing potential, a negative urine pregnancy test must be documented prior to proceeding with chemoradiation. Women of childbearing potential must agree to use medically acceptable forms of adequate contraception (hormonal or barrier method of birth control; or abstinence) for the entire study period and for up to 4 weeks after study treatment
  • Ability to understand and willingness to sign a written informed consent
  • Able to tolerate the taste of the Kate Farms Standard 1.4 or Standard 1.0 oral nutritional supplement at the time of screening
  • Able and willing to participate in the Swallow Preservation Program at the Speech Pathology Clinic
  • No evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation

Exclusion Criteria:

  • Patients who refuse to use Kate Farms oral nutritional meal replacement due to its taste or other patient preference reasons
  • Patients with allergies to any of the ingredients contained in Kate Farms nutritional replacement
  • Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
  • Refusal to sign the informed consent

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Study Stats
Protocol No.
20-002182
Category
Oncology
Radiation Oncology
Principal Investigator
Jie Deng
Contact
Jackie Hernandez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05115760
For detailed technical eligibility, visit ClinicalTrials.gov.