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Active Not Recruiting
NCT07242365
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Conditions: Locally Advanced Head and Neck Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: Jonsson Comprehensive Cancer Center
Location: UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
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. 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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07242365). StuddyBuddy aggregates publicly available trial information.