Active, not recruitingNCT07242365Updated Feb 5, 2026

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

A Phase 2 interventional study of Soylent Graham Dietary Supplement and Laboratory Biomarker Analysis in Locally Advanced Head and Neck Carcinoma, sponsored by Jonsson Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Jonsson Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care

From the registry’s dates

Registered 6 years 3 months after the study started (first participant enrolled Jun 2017, registered Oct 2023).

Phase: Phase 2
Study type: Interventional
Enrollment: 60
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Locally Advanced Head and Neck Carcinoma

In context

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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 design

Phase: Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Supportive care (Soylent)
Patients receive Soylent PO for up to 3 months.
Dietary Supplement: Soylent Graham Dietary Supplement · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

Dietary supplementSoylent Graham Dietary Supplement
Given Soylent PO
Also known as: Dietary Supplement, Dietary Supplements, Nutritional Supplement, Supplement, supplemental nutrition, Supplements
OtherLaboratory Biomarker Analysis
Correlative studies
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment
OtherQuestionnaire Administration
Ancillary studies

What researchers measure

Primary outcomes

Compliance with Soylent nutritional supplementation
The compliance rate and the corresponding 95% exact confidence interval will be calculated.
Time frame: 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.
Time frame: Up to 24 months

Secondary outcomes

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.
Time frame: 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.
Time frame: Up to 24 months
Treatment breaks
Will be recorded in days per study patient and summarized.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
Pre-albumin
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Albumin
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
C-reactive protein
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Interleukin-6
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Tumor necrosis factor
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Vitamin A
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Vitamin C
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Vitamin D
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Tryptophan
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Kynurenine
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Leptin
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Adiponectin
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Complete metabolic panel
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Complete blood count
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: Up to 24 months
Radiosensitivity biomarker panel
Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
Local/loco-regional control
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 24 months
Distant metastasis-free survival
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 24 months
Overall survival
Will be observed.
Time frame: Up to 24 months

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07242365
Lead sponsor: Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Nov 21, 2025
Start date: Jun 19, 2017
Primary completion: Dec 31, 2026 (estimated)
Completion: Dec 31, 2027 (estimated)
Last update: Feb 5, 2026

Study contacts

John Hegde

principal investigator · UCLA / Jonsson Comprehensive Cancer Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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