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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
University of Kentucky
Lexington, Kentucky, United States
Adherence to Treatment
Number of patients completing radiotherapy and three cycles of chemotherapy with no delay
Time frame: Up to 6 weeks
Endurance
Biodex endurance peak torque (Nm)
Time frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Body Composition (Lean Body Mass)
Grams of 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
Peak force (Nm) from one-legged maximum voluntary contraction (MVC) using the Biodex isokinetic machine.
Time frame: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
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