Locally Advanced Head and Neck Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSoylent Graham Dietary Supplement
Given Soylent PO
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented locally advanced head and neck malignancies for which concurrent chemoradiation has been recommended for definitive or adjuvant treatment * No history of prior radiotherapy to the head and neck; however, if previous treatment was superficial skin radiotherapy without regional lymph node treatment this will be allowed * Karnofsky performance status (KPS) \>= 70 * Body mass index \>= 18 kg/m\^2 * No evidence of metastatic disease (M1 disease) * No G-tube placement prior to initiation of chemoradiation * Eligible to undergo concurrent chemotherapy as determined by treating medical oncologist * If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to proceeding with chemoradiation; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment * Ability to understand and willingness to sign a written informed consent * Able to tolerate the taste of one of the flavors of the oral nutritional supplement Soylent * 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 have previously received therapeutic radiation therapy to the head and neck except for superficial skin radiotherapy is allowed * Patients who had G-tube placement due to concern for aspiration or due to severe malnutrition in advance of chemoradiation * Patients underweight in advance of chemoradiation (BMI \< 18 kg/m\^2) * Patients who refuse to use Soylent oral nutritional supplementation due to its taste or other patient preference reasons * Patients with allergies to any of the ingredients contained in the nutritional supplement * Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment * Refusal to sign the informed consent * Refusal to participate in the Swallow Preservation Program prior to start of Soylent if applicable * Evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation * Distant metastatic disease (M1 disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with Soylent nutritional supplementation | Up to 24 months | The compliance rate and the corresponding 95% exact confidence interval will be calculated. |
| Therapeutic gastrostomy (G)-tube placement rate | Up to 24 months | The G-tube placement rate will be analyzed using one-sample exact binomial test. The 95% exact confidence interval will be provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Up to 24 months | 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. |
| Body mass index | Up to 24 months | 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. |
| Treatment breaks | Up to 24 months | Will be recorded in days per study patient and summarized. |
| Timing and duration of G-tube placement | Up to 24 months | 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. |
| Serum human papilloma virus deoxyribonucleic acid | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Pre-albumin | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Albumin | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| C-reactive protein | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Interleukin-6 | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Tumor necrosis factor | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Vitamin A | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Vitamin C | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Vitamin D | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Tryptophan | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Kynurenine | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Leptin | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Adiponectin | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Complete metabolic panel | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Complete blood count | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Radiosensitivity biomarker panel | Up to 24 months | Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically. |
| Incidence of physician-reported acute and late toxicities | Up to 24 months | 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. |
| University of Washington and Functional Assessment of Cancer Therapy questionnaire assessment of Patient-reported quality of life | Up to 24 months | Will be summarized by descriptive statistics by visit time points. |
| Local/loco-regional control | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Distant metastasis-free survival | Up to 24 months | Will be estimated using the Kaplan-Meier method. |
| Overall survival | Up to 24 months | Will be observed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Hegde
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed