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

NCT07242365 | Active Not Recruiting Phase 2 DMC

• 3 other identifiers: 17-000033NCI-2017-01225P30CA016042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (25)

• Weight change

  Up to 24 months

• Body mass index

  Up to 24 months

• Treatment breaks

  Up to 24 months

• Timing and duration of G-tube placement

  Up to 24 months

• Serum human papilloma virus deoxyribonucleic acid

  Up to 24 months

Study Arms (1)

Supportive care (Soylent)

EXPERIMENTAL

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

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (Soylent)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (Soylent)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (Soylent)

Soylent Graham Dietary Supplement DIETARY_SUPPLEMENT

Given Soylent PO

Also known as: Dietary Supplement, Dietary Supplements, Nutritional Supplement, Supplement, supplemental nutrition, Supplements

Supportive care (Soylent)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John Hegde

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 21, 2025
• Study Start: June 19, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2025-07

Locations

US (1)