Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck
Condition: Mucositis
MeSH terms: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Mucositis
Intervention: Beetroot; Placebo
Intervention description: 10g Beetroot powder mixed with 4-8 oz.; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mucositis; Beetroot; Head and neck cancer

Summary:

      The objective of the current proposal is to determine if concentrated beet root could improve
      medical treatment compliance as defined by completion of radiotherapy and 3 cycles of
      chemoradiation without dose reduction, preserve fat-free mass, and strength while reducing
      mucositis. The investigators central hypothesis is that dietary nitrate supplementation in
      head and neck cancer patients receiving aggressive medical care will improve compliance with
      medical treatment by attenuating the loss of muscle mass and strength and reducing symptoms
      (mucositis) associated with treatment compared to patients receiving standard care with
      placebo.
    

Eligibility criteria:

        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).