Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck

This is a parallel 2-arm, 1:1 pilot randomized, placebo controlled supplementation study
designed to examine improvements in chemoradiation compliance, body composition,
strength/endurance, quality of life, nutrition status, and mucositis symptoms by
supplementing beetroot juice over a period of 12 weeks. The Investigators plan to recruit 50
individuals with squamous cell carcinoma of the head and neck who are planning to undergo
chemoradiation. All subjects will be over 18 years of age. Eastern Cooperative Oncology Group
(ECOG) performance status should be less than or equal to 2, which is necessary to ensure the
patient can adequately participate in the supplementation and planned test procedures. All
eligible participants will have a life expectancy greater than or equal to 3 months and
normal organ and marrow function at the time of enrollment.

Inclusion Criteria:

- Patients must have histologically squamous cell carcinoma of the head and neck and be
planned for definitive radiation and chemotherapy.

- Patients must have not received prior radiotherapy or chemotherapy for the current
head and neck cancer. Patients may have a history of prior malignancy, but must be
able to tolerate full dose radiation and chemotherapy for the current head and neck
cancer, as determined by the treating oncologist.

- Age ≥18 years.

- ECOG performance status ≤2

- Life expectancy of greater than 3 months

- Patients must have normal organ and marrow function as defined below:

- leukocytes ≥3,000/mcL

- absolute neutrophil count ≥1,500/mcL

- platelets ≥100,000/mcL

- total bilirubin ≤ 1.5 times ULN (upper limit of normal)

- ALT and AST ≤ 2.5 times the ULN

- Creatinine ≤ 1.5 times ULN OR

- Measured creatinine clearance > 60 mL/min

- Able to swallow thin liquids or have a feeding tube for delivery of nutrition.

- No uncontrolled illness including, but not limited to, any of the following:

- Ongoing or active serious infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled cardiac arrhythmia

- Uncontrolled hypertension

- Psychiatric illness or social situation that would preclude compliance with study

- No other concurrent investigational or anticancer therapies or agents.

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation.

- Men treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study, for the duration of study participation, and 4 months after
completion of beet root administration.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Active infection > CTCAE Grade 2, that is considered clinically serious by the
treating physician.

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
study dietary supplement.

- Patients who are receiving any other investigational agents.

- Pregnant women are excluded from this study because chemo-radiation has the potential
for teratogenic or abortifacient effects. Because there is an unknown but potential
risk for adverse events in nursing infants secondary to treatment of the mother with
chemoradiation, breastfeeding should be discontinued.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with beet root.

- Subjects with a history of calcium oxalate nephrolithiasis.

- Subjects with a significant history of malabsorption (e.g. celiac sprue, short bowel
syndrome, or other, as determined by the treating physician).