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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01225 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 17-000033 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center | |
| P30CA016042 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies Soylent in reducing gastrostomy tube rates in patients with head and neck cancer that has spread to nearby tissues or lymph nodes (locally advanced) who are undergoing chemoradiotherapy. Soylent is a liquid meal replacement product that may reduce the risk of malnutrition and gastrostomy placement during or following treatment for head and neck cancer with chemoradiation.
PRIMARY OBJECTIVES:
I. To determine the compliance rate of oral nutritional replacement with Soylent.
II. To determine the overall therapeutic gastrostomy (G)-tube placement rate (G-tube placement from the 1st day of chemoradiation up to 4 weeks following treatment).
SECONDARY OBJECTIVES:
I. To determine weight loss and body mass index (BMI) changes during and following treatment.
II. To determine the change in nutritional and metabolic biomarkers during treatment.
III. To determine physician-reported acute and late toxicities during and following treatment.
IV. To determine patient-reported quality of life during and following treatment.
V. To determine clinical outcomes from treatment.
OUTLINE:
Patients receive Soylent orally (PO) for up to 3 months.
After completion of study, patients are followed up at 1, 3, 6, 12, 16, 18 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (Soylent) | Experimental | Patients receive Soylent PO for up to 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soylent Graham Dietary Supplement | Dietary Supplement | Given Soylent PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with Soylent nutritional supplementation | The compliance rate and the corresponding 95% exact confidence interval will be calculated. | Up to 24 months |
| Therapeutic gastrostomy (G)-tube placement rate | The G-tube placement rate will be analyzed using one-sample exact binomial test. The 95% exact confidence interval will be provided. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure analysis of variation will be used to explore if there are any change in these parameters over time. | Up to 24 months |
| Body mass index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hegde | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
Will be collected at each visit and summary descriptive statistics will be calculated at each time points. Repeated measure analysis of variation will be used to explore if there are any change in these parameters over time. |
| Up to 24 months |
| Treatment breaks | Will be recorded in days per study patient and summarized. | Up to 24 months |
| Timing and duration of G-tube placement | 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 24 months |
| Serum human papilloma virus deoxyribonucleic acid | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Pre-albumin | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Albumin | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| C-reactive protein | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Interleukin-6 | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Tumor necrosis factor | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Vitamin A | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Vitamin C | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Vitamin D | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Tryptophan | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Kynurenine | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Leptin | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Adiponectin | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Complete metabolic panel | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Complete blood count | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Radiosensitivity biomarker panel | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. | Up to 24 months |
| Incidence of physician-reported acute and late toxicities | Toxicity will be graded using the Common Toxicity Criteria for Adverse Events version 4.0. Adverse events and serious adverse events will be reported using a Common Terminology Criteria for Adverse Events version 4.0 terminology and severity. | Up to 24 months |
| University of Washington and Functional Assessment of Cancer Therapy questionnaire assessment of Patient-reported quality of life | Will be summarized by descriptive statistics by visit time points. | Up to 24 months |
| Local/loco-regional control | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Distant metastasis-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months |
| Overall survival | Will be observed. | Up to 24 months |
| 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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