A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 28
- 主要终点
- Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer.
PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.
详细描述
OBJECTIVES:
- Compare the disease-free survival of patients with stage I-IV (including stage IVA and IVB) head and neck cancer treated with fruit and vegetable extracts vs placebo.
- Compare the effect of these extracts on biomarkers (p27 expression, cell proliferation of Ki-67, DNA damage, and T-cell function) in these patients.
- Correlate changes in biomarkers with other factors (e.g., site and stage of the original tumors, tobacco/alcohol use, or depression) in patients treated with these extracts.
- Compare serum carotenoids and antioxidant levels (vitamins A, C, and E) at baseline and posttreatment in patients treated with these extracts.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to tobacco use (yes vs no), alcohol consumption (yes vs no), and tumor stage at diagnosis (I vs II vs III vs IVA vs IVB). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral fruit and vegetable extracts twice daily.
- Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed annually for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •DISEASE CHARACTERISTICS:
- •Curatively treated stage I-IV (including stage IVA and IVB) squamous cell carcinoma of the upper aerodigestive tract of 1 of the following primary sites:
- •Oral cavity
- •Oropharynx
- •Hypopharynx
- •Disease-free for at least 6 months and no more than 3 years after completion of surgery, radiotherapy, and/or chemotherapy
- •No synchronous tumors
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100% OR
- •Zubrod 0-1
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Hemoglobin ≥ 10 g/dL
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 mg/dL
- •SGOT ≤ 40 U/L
- •SGPT ≤ 56 U/L
- •Creatinine ≤ 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except curatively treated head and neck squamous cell carcinoma, nonmelanoma skin cancer, or carcinoma in situ of the cervix
- •No other serious medical or psychiatric illness that would preclude giving informed consent
- •No nausea ≥ grade 2
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •More than 6 months and less than 3 years since prior chemotherapy
- •No concurrent chemotherapy
- •No other concurrent chemopreventive agents
- •Endocrine therapy
- •More than 6 months and less than 3 years since prior hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- •More than 6 months and less than 3 years since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •More than 6 months and less than 3 years since prior surgery
- •No concurrent surgery
- •More than 6 months and less than 3 years since prior investigational agents
- •More than 2 months since prior high-dose vitamins (i.e., 10 times the recommended daily allowance [8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of vitamin E])
排除标准
- 未提供
研究组 & 干预措施
Arm I - JuicePlus
Patients receive oral fruit and vegetable extracts twice daily.
干预措施: fruit and vegetable extracts (Dietary Supplement)
Arm II - Control
Patients receive oral placebo twice daily.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12
时间窗: baseline and 12 weeks
Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.
次要结局
- Cell Proliferation (Ki-67) at Baseline and Week 12(baseline and 12 weeks)