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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

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ClinicalTrials.gov Identifier: NCT05115760
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : March 24, 2022
Sponsor:
Collaborator:
Kate Farms, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Locally Advanced Head and Neck Carcinoma Dietary Supplement: Dietary Supplement Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : June 1, 2026
Estimated Study Completion Date : June 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive care (pea protein oral nutrition supplement)
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
Given Kate Farms pea protein oral nutrition supplement PO
Other Names:
  • Dietary Supplements
  • Nutritional Supplement
  • Supplement
  • supplemental nutrition
  • Supplements

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Compliance rate [ Time Frame: Up to 1 month post chemoradiation ]
    Will calculate the compliance rate and the corresponding 95% exact confidence interval.

  2. Gastrostomy (G)-tube placement rate [ Time Frame: Up to 1 month post chemoradiation ]
    Will calculate the compliance rate and the corresponding 95% exact confidence interval. The 95% exact confidence interval (CI) will be provided.


Secondary Outcome Measures :
  1. Weight change measurement [ Time Frame: Up to 2 years ]
    Weight data will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure analysis of variance (ANOVA) will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.

  2. Body mass index change measurement (BMI) [ Time Frame: Up to 2 years ]
    BMI data will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure ANOVA will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.

  3. Global Leadership Initiative on Malnutrition criteria [ Time Frame: Up to 2 years ]
    Will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure ANOVA will be used to explore if there are any change in these parameters over time. Treatment breaks will be recorded in days per study patient and summarized. G-tube placement timing will be recorded for patients receiving G-tubes, and the duration of G-tube dependence will be recorded in days per study patient and summarized.

  4. Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL). [ Time Frame: Up to 2 years ]

    Patient-reported QOL according to the University of Washington (UW-QOL) questionnaires will be summarized by descriptive statistics by visit time points.

    The University of Washington Quality of Life Questionnaire (UW-QOL) is a self-administered scale measuring health-related quality life specifically for head and neck cancer patients. It is scored from 0-100 with higher scores indicating a better quality of life.


  5. Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN). [ Time Frame: Up to 2 years ]

    Patient-reported QOL according to the Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) questionnaires will be summarized by descriptive statistics by visit time points.

    Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) is a 12 item self-administered scale measuring health-related quality of life specifically for head and neck cancer patients. Response options form a Likert scale and a subscale score is computed by summing across all items, with higher scores reflecting better QOL.


  6. Local/locoregional control [ Time Frame: Up to 2 years ]
    Will be estimated using the Kaplan-Meier method.

  7. Distant metastasis-free survival [ Time Frame: Up to 2 years ]
    Will be estimated using the Kaplan-Meier method.

  8. Overall survival [ Time Frame: Up to 2 years ]
    Will be estimated using the Kaplan-Meier method.

  9. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
    Toxicity will be graded using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version (v) 4.0. AEs and serious (S)AEs will be reported using a CTCAE v 4.0 terminology and severity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05115760


Contacts
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Contact: Vincent Basehart 310 267-8954 vbasehart@mednet.ucla.edu
Contact: Jackie Hernandez 310 206-8477 ext 97624 jhernandez@mednet.ucla.edu

Locations
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United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Jackie Hernandez    310-206-8477 ext 97624    jhernandez@mednet.ucla.edu   
Principal Investigator: Jie Deng         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Kate Farms, Inc.
Investigators
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Principal Investigator: Jie Deng UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05115760    
Other Study ID Numbers: 20-002182
NCI-2021-03612 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms