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

NCT05115760 | Active Not Recruiting DMC

• 2 other identifiers: 20-002182NCI-2021-03612
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• Compliance rate

  Will calculate the compliance rate and the corresponding 95% exact confidence interval.

  Up to 1 month post chemoradiation

• Gastrostomy (G)-tube placement rate

  Will calculate the compliance rate and the corresponding 95% exact confidence interval. The 95% exact confidence interval (CI) will be provided.

  Up to 1 month post chemoradiation

Secondary Outcomes (9)

• Weight change measurement

  Up to 2 years

• Body mass index change measurement (BMI)

  Up to 2 years

• Global Leadership Initiative on Malnutrition criteria

  Up to 2 years

• Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL).

  Up to 2 years

• Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN).

  Up to 2 years

Study Arms (1)

Supportive care (pea protein oral nutrition supplement)

EXPERIMENTAL

Patients receive Kate Farms pea protein oral nutrition supplement PO during their mealtimes as directed by their clinical dietitian during and up to 1 month following chemoradiation in the absence of unacceptable toxicity.

Dietary Supplement: Dietary Supplement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Dietary Supplement DIETARY_SUPPLEMENT

Given Kate Farms pea protein oral nutrition supplement PO

Also known as: Dietary Supplements, Nutritional Supplement, Supplement, supplemental nutrition, Supplements

Supportive care (pea protein oral nutrition supplement)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (pea protein oral nutrition supplement)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (pea protein oral nutrition supplement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• While negative pregnancy would be verified by urine test routinely prior to chemo-radiation therapy, we do not ask for verification of a negative urine pregnancy test.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Kate Farms Inc: collaborator

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jie Deng

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: November 10, 2021
• Study Start: April 5, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)