MucositisPhase 2NCT02058849
Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck
A Phase 2 study testing Beetroot in people with Mucositis, run by David Travis Thomas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- Beetroot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 1 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 25Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mucositis
- Being tested
- Beetroot, Placebo
- Keywords
- Mucositis, Beetroot, Head and neck cancer
- Medical subject headings
- Mucositis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeetrootDrug
Also called BEETELITE™ NeO Shot
10g Beetroot powder mixed with 4-8 oz.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Beetroot | Experimental | Beetroot 10 grams concentrated organic beetroot crystals Receives: Drug: Beetroot |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Treatment
Number of patients completing radiotherapy and three cycles of chemotherapy with no delay
Measured: Up to 6 weeks
Endurance
Biodex endurance peak torque (Nm)
Measured: 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)
Grams of lean body mass
Measured: 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.
Measured: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startDec 2014
- Primary completion1 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Travis Thomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Travis Thomas, University of Kentucky
- Investigators
- Travis Thomas, PH.D., RD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058849
- Sponsor's protocol ID
- 13-HN-23-MCC
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2014
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02058849
- Acronym / sponsor ID
- 13-HN-23-MCC
- Conditions
- Mucositis
- Keywords
- Mucositis, Beetroot, Head and neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- David Travis ThomasUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot | Experimental | Drug: BeetrootBeetroot 10 grams concentrated organic beetroot crystals |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeetrootAlso: BEETELITE™ NeO Shot10g Beetroot powder mixed with 4-8 oz. | Drug | Beetroot |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Adherence to Treatment
Time frame: Up to 6 weeks
Number of patients completing radiotherapy and three cycles of chemotherapy with no delay
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)
2 secondary outcomes
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).
Muscle Strength
Time frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Travis Thomas, PH.D., RD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beetroot in people with Mucositis, run by David Travis Thomas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Treatment (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.