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

Randomized Phase II Study of Concentrated Beet Root in Participants Being Treated for Locally Advanced Unresectable, Previously Untreated Squamous Cell Cancer of the Head and Neck

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.

Study Overview

• Status: Completed
• Conditions: Mucositis
• Intervention / Treatment: Other: Placebo; Drug: Beetroot

Detailed Description

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/intensity-modulated radiation therapy (IMRT). 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: Beetroot; Beetroot 10 grams concentrated organic beetroot crystals	Drug: Beetroot; 10g Beetroot powder mixed with 4-8 oz.; Other Names: BEETELITE™ NeO Shot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Treatment	Number of patients completing radiotherapy and three cycles of chemotherapy with no delay	Up to 6 weeks
Endurance	Biodex endurance peak torque (Nm)	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition (Lean Body Mass)	Grams of lean body mass	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Muscle Strength	Peak force (Nm) from one-legged maximum voluntary contraction (MVC) using the Biodex isokinetic machine.	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip Strength	Peak force (kg) measured using a handgrip dynamometer	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Handgrip Strength at 30 Seconds	Handgrip strength (kg) at 30 seconds measured using a handgrip dynamometer	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Body Fat	Grams of body fat	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Bone Mineral Content	Bone mineral content (grams).	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Bone Mineral Density	Bone mineral density (grams per centimeter squared)	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Fat Free Mass	Kilograms of fat free mass	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Total Body Mass	Kilograms of body mass	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

Collaborators and Investigators

• Sponsor: David Travis Thomas
• Investigators: Principal Investigator: Travis Thomas, PH.D., RD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Mucositis; Head and neck cancer; Beetroot
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Mucositis; Neoplasms, Squamous Cell
• Other Study ID Numbers: 13-HN-23-MCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No