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Locally Advanced Head and Neck CarcinomaPhase 2NCT07242365

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

A Phase 2 study testing Soylent Graham Dietary Supplement, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Locally Advanced Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced Head and Neck Carcinoma
What is being tested?
Soylent Graham Dietary Supplement, Laboratory Biomarker Analysis and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
19 Jun 2017to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase II Study Integrating Soylent&#8482; 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
Soylent Graham Dietary Supplement, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soylent Graham Dietary SupplementDietary supplement

    Also called Dietary Supplement, Dietary Supplements, Nutritional Supplement, Supplement

    Given Soylent PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07242365
Study groupRoleWhat they receive
Supportive care (Soylent)ExperimentalPatients receive Soylent PO for up to 3 months.
Receives: Dietary Supplement: Soylent Graham Dietary Supplement; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance with Soylent nutritional supplementation

    The compliance rate and the corresponding 95% exact confidence interval will be calculated.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

Secondary outcomes (25)

  1. 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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

  3. Treatment breaks

    Will be recorded in days per study patient and summarized.

    Measured: Up to 24 months

  4. 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.

    Measured: Up to 24 months

  5. Serum human papilloma virus deoxyribonucleic acid

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  6. Pre-albumin

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  7. Albumin

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  8. C-reactive protein

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  9. Interleukin-6

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  10. Tumor necrosis factor

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  11. Vitamin A

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  12. Vitamin C

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  13. Vitamin D

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  14. Tryptophan

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  15. Kynurenine

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  16. Leptin

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  17. Adiponectin

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  18. Complete metabolic panel

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  19. Complete blood count

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  20. Radiosensitivity biomarker panel

    Will be summarized by descriptive statistics by visit time points, and these statistics will be plotted graphically.

    Measured: Up to 24 months

  21. 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.

    Measured: Up to 24 months

  22. 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.

    Measured: Up to 24 months

  23. Local/loco-regional control

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  24. Distant metastasis-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 24 months

  25. Overall survival

    Will be observed.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start19 Jun 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07242365
Sponsor's protocol ID
17-000033
Other IDs
NCI-2017-01225, 17-000033, P30CA016042
Status last verified
Nov 2026
First submitted
13 Oct 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Soylent Graham Dietary Supplement, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Locally Advanced Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance with Soylent nutritional supplementation (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07242365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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