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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02058849

Enrollment

Registered

2014-02-10

Start date

2014-12-31

Completion date

2018-05-01

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis

Keywords

Mucositis, Beetroot, Head and neck cancer

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.

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.

Interventions

DRUGBeetroot

10g Beetroot powder mixed with 4-8 oz.

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Muscle Strength	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.
Body Composition (Lean Body Mass)	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).	Grams of lean body mass

Other

Measure	Time frame	Description
Bone Mineral Density	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)
Handgrip Strength	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
Total Body Mass	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).	Kilograms of body mass
Fat Free Mass	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).	Kilograms of fat free mass
Handgrip Strength at 30 Seconds	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
Body Fat	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).	Grams of body fat
Bone Mineral Content	Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).	Bone mineral content (grams).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Beetroot Beetroot 10 grams concentrated organic beetroot crystals Beetroot: 10g Beetroot powder mixed with 4-8 oz.	11
Placebo Placebo Placebo: Placebo	2
Total	13

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	1	0
Overall Study	Hospitalization	1	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Withdrawal by Subject	4	0

Baseline characteristics

Characteristic	Beetroot	Total	Placebo
Age, Continuous	53 years	51 years	49 years
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	13 Participants	2 Participants
Region of Enrollment United States	11 Participants	13 Participants	2 Participants
Sex: Female, Male Female	2 Participants	2 Participants	0 Participants
Sex: Female, Male Male	9 Participants	11 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 11	0 / 2
other Total, other adverse events	9 / 11	2 / 2
serious Total, serious adverse events	0 / 11	0 / 2

Outcome results

Primary

Adherence to Treatment

Number of patients completing radiotherapy and three cycles of chemotherapy with no delay

Time frame: Up to 6 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Beetroot	Adherence to Treatment	4 Participants
Placebo	Adherence to Treatment	1 Participants

Primary