Clinical trial NCT02058849: Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis
Keywords: Mucositis
Beetroot
Head and neck cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adherence to Treatment
timeFrame: Up to 6 weeks
measure: Endurance
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Secondary outcomes:
measure: Body Composition (Lean Body Mass)
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Muscle Strength
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Other outcomes:
measure: Handgrip Strength
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Handgrip Strength at 30 Seconds
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Body Fat
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Bone Mineral Content
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Bone Mineral Density
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Fat Free Mass
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
measure: Total Body Mass
timeFrame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Travis Thomas, PH.D., RD
role: PRINCIPAL_INVESTIGATOR
References: