Trial Outcomes & Findings for Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck (NCT NCT02058849)
NCT ID: NCT02058849
Last Updated: 2019-08-14
Results Overview
Number of patients completing radiotherapy and three cycles of chemotherapy with no delay
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Beetroot
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
2
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Beetroot
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Hospitalization
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck
Baseline characteristics by cohort
| Measure |
Beetroot
n=11 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=2 Participants
Placebo
Placebo: Placebo
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=39 Participants
|
49 years
n=41 Participants
|
51 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksNumber of patients completing radiotherapy and three cycles of chemotherapy with no delay
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Adherence to Treatment
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Biodex endurance peak torque (Nm)
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Endurance
Baseline (1-2 weeks pre-IMRT)
|
161.2 Nm
Standard Deviation 31.3
|
129 Nm
|
|
Endurance
Midpoint (7-8 weeks following IMRT initiation)
|
116.0 Nm
Standard Deviation 22.2
|
139.8 Nm
|
|
Endurance
Endpoint (4-6 weeks following Midpoint)
|
122.7 Nm
Standard Deviation 23.5
|
95.2 Nm
|
SECONDARY outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Grams of lean body mass
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Body Composition (Lean Body Mass)
Baseline (1-2 weeks pre-IMRT)
|
59245.3 grams
Standard Deviation 11120.8
|
63469 grams
|
|
Body Composition (Lean Body Mass)
Midpoint (7-8 weeks following IMRT initiation)
|
51524.0 grams
Standard Deviation 10650.5
|
60833 grams
|
|
Body Composition (Lean Body Mass)
Endpoint (4-6 weeks following Midpoint)
|
52170.0 grams
Standard Deviation 10969.9
|
57005 grams
|
SECONDARY outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Population: Midpoint data were not collected from the placebo group for this outcome.
Peak force (Nm) from one-legged maximum voluntary contraction (MVC) using the Biodex isokinetic machine.
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Muscle Strength
Baseline (1-2 weeks pre-IMRT)
|
176.1 Nm
Standard Deviation 4.2
|
120.3 Nm
|
|
Muscle Strength
Midpoint (7-8 weeks following IMRT initiation)
|
149.8 Nm
Standard Deviation 26.1
|
NA Nm
Midpoint data were not collected from the placebo group for this outcome.
|
|
Muscle Strength
Endpoint (4-6 weeks following Midpoint)
|
162.6 Nm
Standard Deviation 27.5
|
133.6 Nm
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Handgrip Strength
Baseline (1-2 weeks pre-IMRT)
|
53.2 kg
Standard Deviation 12.3
|
35 kg
|
|
Handgrip Strength
Midpoint (7-8 weeks following IMRT initiation)
|
48.2 kg
Standard Deviation 12.0
|
33.3 kg
|
|
Handgrip Strength
Endpoint (4-6 weeks following Midpoint)
|
46.8 kg
Standard Deviation 10.9
|
32.5 kg
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Handgrip Strength at 30 Seconds
Baseline (1-2 weeks pre-IMRT)
|
28.7 kg
Standard Deviation 2.7
|
18 kg
|
|
Handgrip Strength at 30 Seconds
Midpoint (7-8 weeks following IMRT initiation)
|
26.7 kg
Standard Deviation 3.6
|
21.5 kg
|
|
Handgrip Strength at 30 Seconds
Endpoint (4-6 weeks following Midpoint)
|
25.0 kg
Standard Deviation 9.7
|
22.5 kg
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Grams of body fat
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Body Fat
Endpoint (4-6 weeks following Midpoint)
|
26075.5 grams
Standard Deviation 9173.5
|
37713 grams
|
|
Body Fat
Baseline (1-2 weeks pre-IMRT)
|
29478.8 grams
Standard Deviation 11003.8
|
44528 grams
|
|
Body Fat
Midpoint (7-8 weeks following IMRT initiation)
|
27093.3 grams
Standard Deviation 10889.1
|
45419 grams
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Bone mineral content (grams).
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Bone Mineral Content
Baseline (1-2 weeks pre-IMRT)
|
3011.7 grams
Standard Deviation 569.7
|
3728 grams
|
|
Bone Mineral Content
Midpoint (7-8 weeks following IMRT initiation)
|
2651.5 grams
Standard Deviation 664.4
|
3719 grams
|
|
Bone Mineral Content
Endpoint (4-6 weeks following Midpoint)
|
2020.5 grams
Standard Deviation 1315.7
|
3668 grams
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Population: Midpoint data were not collected from the placebo group for this outcome.
Bone mineral density (grams per centimeter squared)
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Bone Mineral Density
Baseline (1-2 weeks pre-IMRT)
|
1.2 grams per centimeter squared
Standard Deviation 0.2
|
1.4 grams per centimeter squared
|
|
Bone Mineral Density
Midpoint (7-8 weeks following IMRT initiation)
|
1.1 grams per centimeter squared
Standard Deviation 0.2
|
NA grams per centimeter squared
Midpoint data were not collected from the placebo group for this outcome.
|
|
Bone Mineral Density
Endpoint (4-6 weeks following Midpoint)
|
1.1 grams per centimeter squared
Standard Deviation 0.2
|
1.3 grams per centimeter squared
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Population: Midpoint data were not collected from the placebo group for this outcome.
Kilograms of fat free mass
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Fat Free Mass
Baseline (1-2 weeks pre-IMRT)
|
28.1 kilograms
Standard Deviation 9.4
|
67.2 kilograms
|
|
Fat Free Mass
Midpoint (7-8 weeks following IMRT initiation)
|
27.7 kilograms
Standard Deviation 11.9
|
NA kilograms
Midpoint data were not collected from the placebo group for this outcome.
|
|
Fat Free Mass
Endpoint (4-6 weeks following Midpoint)
|
35.8 kilograms
Standard Deviation 22.1
|
37.7 kilograms
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).Kilograms of body mass
Outcome measures
| Measure |
Beetroot
n=4 Participants
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=1 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Total Body Mass
Baseline (1-2 weeks pre-IMRT)
|
87.4 kilograms
Standard Deviation 19.9
|
111.7 kilograms
|
|
Total Body Mass
Midpoint (7-8 weeks following IMRT initiation)
|
81.3 kilograms
Standard Deviation 14.7
|
NA kilograms
Midpoint data were not collected from the placebo group for this outcome.
|
|
Total Body Mass
Endpoint (4-6 weeks following Midpoint)
|
80.9 kilograms
Standard Deviation 12.8
|
98.4 kilograms
|
Adverse Events
Beetroot
Serious events: 0 serious events
Other events: 9 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Beetroot
n=11 participants at risk
Beetroot 10 grams concentrated organic beetroot crystals
Beetroot: 10g Beetroot powder mixed with 4-8 oz.
|
Placebo
n=2 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Ear and labyrinth disorders
Tinnitus
|
18.2%
2/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Ear and labyrinth disorders
External ear pain
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Eye disorders
Vitreous hemorrhage
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 4 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Dry mouth
|
18.2%
2/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • 4 months
see protocol
|
50.0%
1/2 • Number of events 1 • 4 months
see protocol
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
2/11 • Number of events 4 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Esophagitis
|
9.1%
1/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Mucositis oral
|
81.8%
9/11 • Number of events 10 • 4 months
see protocol
|
50.0%
1/2 • Number of events 1 • 4 months
see protocol
|
|
Gastrointestinal disorders
Nausea
|
63.6%
7/11 • Number of events 8 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Oral pain
|
45.5%
5/11 • Number of events 5 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
General disorders
Fatigue
|
36.4%
4/11 • Number of events 6 • 4 months
see protocol
|
50.0%
1/2 • Number of events 1 • 4 months
see protocol
|
|
General disorders
Pain
|
18.2%
2/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
General disorders
Edema limbs
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Infections and infestations
Infections and infestations - Other, specify
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Infections and infestations
Wound infection
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Infections and infestations
Bronchial infection
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Infections and infestations
Esophageal infection
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
36.4%
4/11 • Number of events 5 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Investigations
Lymphocyte count decreased
|
36.4%
4/11 • Number of events 4 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Investigations
Weight loss
|
18.2%
2/11 • Number of events 2 • 4 months
see protocol
|
50.0%
1/2 • Number of events 1 • 4 months
see protocol
|
|
Investigations
White blood cell decreased
|
18.2%
2/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.3%
3/11 • Number of events 3 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Nervous system disorders
Dysphasia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
50.0%
1/2 • Number of events 1 • 4 months
see protocol
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
27.3%
3/11 • Number of events 4 • 4 months
see protocol
|
50.0%
1/2 • Number of events 1 • 4 months
see protocol
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.1%
1/11 • Number of events 2 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Number of events 1 • 4 months
see protocol
|
0.00%
0/2 • 4 months
see protocol
|
Additional Information
Dr. Travis Thomas, Associate Professor
University of Kentucky
Phone: 859-218-0863
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place