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

NCT02058849 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 13-HN-23-MCC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucositis

Keywords

Mucositis; Beetroot; Head and neck cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Body Composition (Lean Body Mass)

  Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

• Muscle Strength

  Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

Other Outcomes (7)

• Handgrip Strength

  Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

• Handgrip Strength at 30 Seconds

  Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

• Body Fat

  Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).

Study Arms (2)

Beetroot

EXPERIMENTAL

Beetroot 10 grams concentrated organic beetroot crystals

Drug: Beetroot

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Beetroot DRUG

10g Beetroot powder mixed with 4-8 oz.

Also known as: BEETELITE™ NeO Shot

Beetroot

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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).

Sponsors & Collaborators

• David Travis Thomas: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Mucositis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Limitations and Caveats

The trial ended with only one participant in the placebo group. Intra-group and comparative statistics were thus not possible.

Results Point of Contact

• Title: Dr. Travis Thomas, Associate Professor
• Organization: University of Kentucky

dth225@uky.edu

859-218-0863

Study Officials

• Travis Thomas, PH.D., RD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: February 10, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)