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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Endurance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Beetroot
Beetroot 10 grams concentrated organic beetroot crystals
干预措施: Beetroot (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Endurance
时间窗: Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).
Biodex endurance peak torque (Nm)
Adherence to Treatment
时间窗: Up to 6 weeks
Number of patients completing radiotherapy and three cycles of chemotherapy with no delay
次要结局
- Muscle Strength(Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).)
- Body Composition (Lean Body Mass)(Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).)
研究者
David Travis Thomas
Associate Professor
University of Kentucky