Clinical trial NCT05115760: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Head and Neck Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Kate Farms Inc
First posted: 2021-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the therapeutic G-tube placement rate during chemoradiation.

SECONDARY OBJECTIVES:

I. To determine percent weight change during and following treatment. II. To determine body mass index (BMI) changes during and following treatment. III. To determine changes in nutrition status based on Global Leadership Initiative on Malnutrition (GLIM) criteria IV. To determine lean body mass before and after treatment via psoas muscle surrogate measurement on routine staging scans.

V. To determine the adherence rate of Kate Farms oral nutritional replacement. VI. To determine changes in oral and gastrointestinal microbiota via 16s ribosomal ribonucleic acid (RNA) sequencing during and following treatment in an exploratory analysis.

VII. To determine changes in biomarkers during treatment. VIIa. Serum human papillomavirus (HPV) deoxyribonucleic (DNA). VIIb. 38-multiplex immune cytokine and chemokine panel in an exploratory analysis.

VIIc. Complete metabolic panel, complete blood count with differential, C-reactive protein (CRP).

VIId. Radiosensitivity germ-line biomarker panel. VIII. To determine physician-reported acute and late toxicities during and following treatment.

VIIIa. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. IX. To determine patient-reported quality of life during and following treatment.

IXa. University of Washington and Functional Assessment of Cancer Therapy questionnaires.

IXb. Functional Assessment of Cancer Therapy-Head \& Neck (FACT-H\&N). X. To determine clinical outcomes from treatment. Xa. Local/Locoregional control. Xb. Distant metastasis-free survival. Xc. Overall survival.

OUTLINE:

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

After completion of study intervention, patients are followed up for a minimum of 2 years.

Eligibility criteria: 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
* 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

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

Primary outcomes:
measure: Compliance rate
timeFrame: Up to 1 month post chemoradiation
measure: Gastrostomy (G)-tube placement rate
timeFrame: Up to 1 month post chemoradiation
Secondary outcomes:
measure: Weight change measurement
timeFrame: Up to 2 years
measure: Body mass index change measurement (BMI)
timeFrame: Up to 2 years
measure: Global Leadership Initiative on Malnutrition criteria
timeFrame: Up to 2 years
measure: Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL).
timeFrame: Up to 2 years
measure: Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN).
timeFrame: Up to 2 years
measure: Local/locoregional control
timeFrame: Up to 2 years
measure: Distant metastasis-free survival
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
measure: Incidence of adverse events (AEs)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jie Deng
role: PRINCIPAL_INVESTIGATOR
References: