Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy

Open to people ages 18 years and up

• 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/m²
• 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

• 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/m²)
• 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)