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Could a simple drink replace feeding tubes for head and neck cancer patients?

NCT ID NCT07242365

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether Soylent, a liquid meal replacement, can help head and neck cancer patients avoid needing a feeding tube during chemoradiotherapy. About 60 patients with locally advanced cancer will drink Soylent alongside their treatment. The goal is to see if this reduces malnutrition and the need for gastrostomy tube placement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Soylent liquid meal replacement
What this could lead to
If it works, this could offer a simple nutritional drink to help patients avoid feeding tubes during cancer treatment.
What could go wrong
This is a small, early-phase study with only 60 participants, so results may not apply to everyone. The drink may not be enough to prevent malnutrition or tube placement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2017

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.