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

Jonsson Comprehensive Cancer Center

Status and phase

Active, not recruiting

Phase 2

Conditions

Locally Advanced Head and Neck Carcinoma

Treatments

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Dietary Supplement: Soylent Graham Dietary Supplement

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07242365

NCI-2017-01225 (Registry Identifier)

17-000033 (Other Identifier)

P30CA016042 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)