Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Soylent Graham Dietary Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (Soylent)
- description
- Patients receive Soylent PO for up to 3 months.
- interventionNames
- Dietary Supplement: Soylent Graham Dietary Supplement
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Compliance with Soylent nutritional supplementation
- timeFrame
- Up to 24 months
- description
- The compliance rate and the corresponding 95% exact confidence interval will be calculated.
- measure
- Therapeutic gastrostomy (G)-tube placement rate
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available