Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy

A Phase II Study Integrating Soylent™ Meal Replacement to Reduce Gastrostomy Tube Rates in Patients With Head &Amp; Neck Cancer Undergoing Chemoradiotherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Locally Advanced Head and Neck Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Dietary supplement: Soylent Graham Dietary Supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (Soylent); Patients receive Soylent PO for up to 3 months.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Dietary supplement: Soylent Graham Dietary Supplement; Given Soylent PO; Other Names: Dietary Supplement; Nutritional Supplement; Dietary Supplements; Supplement; supplemental nutrition; Supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: John Hegde, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: 17-000033 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); P30CA016042 (U.S. NIH Grant/Contract); NCI-2017-01225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No