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

PRIMARY OBJECTIVES:

I. To determine the compliance rate of oral nutritional replacement with Soylent.

II. To determine the overall therapeutic gastrostomy (G)-tube placement rate (G-tube placement from the 1st day of chemoradiation up to 4 weeks following treatment).

SECONDARY OBJECTIVES:

I. To determine weight loss and body mass index (BMI) changes during and following treatment.

II. To determine the change in nutritional and metabolic biomarkers during treatment.

III. To determine physician-reported acute and late toxicities during and following treatment.

IV. To determine patient-reported quality of life during and following treatment.

V. To determine clinical outcomes from treatment.

OUTLINE:

Patients receive Soylent orally (PO) for up to 3 months.

After completion of study, patients are followed up at 1, 3, 6, 12, 16, 18 and 24 months.

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)