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

July 26, 2019 updated by: David Travis Thomas

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to Treatment
Time Frame: Up to 6 weeks
Number of patients completing radiotherapy and three cycles of chemotherapy with no delay
Up to 6 weeks
Endurance
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition (Lean Body Mass)
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip Strength
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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
Time Frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
David Travis Thomas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Travis Thomas, PH.D., RD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings