Soylent for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Metastatic disease, Underweight, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Soylent, a liquid meal replacement, can reduce the need for feeding tubes in people with head and neck cancer undergoing chemoradiotherapy. The research focuses on preventing malnutrition by using Soylent during cancer treatment. People with locally advanced head and neck cancer, recommended for chemoradiation and without prior radiation in the area or a feeding tube, might be suitable candidates. Participants must be able to drink Soylent and be willing to join a swallowing program. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Soylent is likely to be safe for humans?

Research has shown that Soylent is generally easy for patients to handle. In a study with head and neck cancer patients receiving chemoradiotherapy, those using Soylent adhered well, with only 5% requiring a feeding tube inserted into the stomach. This indicates that most patients can use Soylent without major issues. Additionally, these studies report no serious side effects from Soylent. As a meal replacement already used by many for nutrition, Soylent's safety is well-supported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Most treatments for head and neck cancer involve a combination of surgery, radiation, and chemotherapy, which can be quite aggressive and have significant side effects. Soylent is unique because it's a nutritional supplement that provides supportive care, potentially enhancing the patient's overall well-being during treatment. Unlike traditional therapies, which directly target cancer cells, Soylent aims to improve nutritional intake and energy levels, helping patients maintain strength and possibly tolerate other treatments better. Researchers are excited because it could offer a less invasive way to support patient health and improve quality of life during cancer treatment.

What evidence suggests that Soylent might be an effective treatment for head and neck cancer?

Research shows that Soylent might reduce the need for feeding tubes in patients with head and neck cancer undergoing chemotherapy and radiation. In this trial, participants will receive Soylent as supportive care. Previous studies have shown that patients using Soylent as a meal replacement had a low rate of needing feeding tubes, only 5%. This suggests Soylent can effectively support nutrition, which is crucial during cancer treatment. These findings highlight Soylent's potential to meet nutritional needs and improve patients' quality of life during therapy. ^{1 2 3 5 6}

Who Is on the Research Team?

John Hegde

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with locally advanced head and neck cancer who are undergoing chemoradiotherapy. It aims to see if Soylent, a liquid meal replacement, can reduce the need for gastrostomy tubes by preventing malnutrition during treatment.

Inclusion Criteria

Body mass index >= 18 kg/m^2

My cancer has not spread to distant parts of my body.

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Soylent orally for up to 3 months during chemoradiotherapy

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

24 months

Follow-up visits at 1, 3, 6, 12, 16, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Soylent

Trial Overview

The study is testing whether Soylent can lower the rates of gastrostomy tube placement in patients. Participants will use Soylent as a dietary supplement alongside their standard care which includes chemoradiotherapy, and their nutrition levels will be monitored.

How Is the Trial Designed?

Group I: Supportive care (Soylent) Experimental Treatment 4 Interventions

Patients receive Soylent PO for up to 3 months.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11747389/

Patient-reported quality of life and adherence outcomes ...

We report high patient adherence and a 5% G-tube placement rate with exclusive meal replacement with Soylent in patients undergoing concurrent CRT for head and ...

2.

soylent.com

soylent.com/pages/soylent-clinical-trials

Soylent Clinical Trials: Efficacy, Safety, and Results

Explore summaries of Soylent's clinical trials, revealing insights into effectiveness, safety, and outcomes. Discover the science behind Soylent's ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39839777/

Patient-reported quality of life and adherence outcomes ...

Conclusions: We report high patient adherence and a 5% G-tube placement rate with exclusive meal replacement with Soylent in patients undergoing concurrent CRT ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07242365?lastUpdPost=2020-01-16_

Soylent in Reducing Gastrostomy Tube Rates in Patients ...

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 ...

5.

redjournal.org

redjournal.org/article/S0360-3016(19)32459-9/pdf

Integrating Exclusive Liquid Meal Replacement ...

Conclusion: Preliminary results suggest that a nutritional management paradigm incorporating Soylent appears to be a tolerable and effective strategy for ...

6.

soylent.com

soylent.com/blogs/news/a-dietitian-s-view-on-clinical-research

A Dietitian's View on Clinical Research | Meal Replacements

- Soylent could be an effective way to prevent cancer patients from losing excessive weight during treatment. - UCLA (Department of Radiation Oncology, ...