NCT07242365

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Head and Neck Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soylent Graham Dietary Supplement	Given Soylent PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-06-19
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-11-21
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States