NCT07242365Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- 19 Jun 2017
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT07242365
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 19 Jun 2017 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
Other illness
- Patients with allergies to any of the ingredients contained in the nutritional supplement
- Distant metastatic disease (M1 disease)
Other
- Patients who refuse to use Soylent oral nutritional supplementation due to its taste or other patient preference reasons
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.