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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03612 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Kate Farms Inc | INDUSTRY |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement | Dietary Supplement | Given Kate Farms pea protein oral nutrition supplement PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change measurement | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Deng | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095 | United States |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 2 years |
| Body mass index change measurement (BMI) | 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. | Up to 2 years |
| Global Leadership Initiative on Malnutrition criteria | 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. | Up to 2 years |
| Patient-reported quality of life (QOL): The University of Washington Quality of Life Questionnaire (UW-QOL). | 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. | Up to 2 years |
| Patient-reported quality of life (QOL): The Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN). | 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. | Up to 2 years |
| Local/locoregional control | Will be estimated using the Kaplan-Meier method. | Up to 2 years |
| Distant metastasis-free survival | Will be estimated using the Kaplan-Meier method. | Up to 2 years |
| Overall survival | Will be estimated using the Kaplan-Meier method. | Up to 2 years |
| Incidence of adverse events (AEs) | 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. | Up to 2 years |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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