A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Relationship between the length of short-term LBR administration to human oral cancer patients and the modulation, in oral cavity tissues, of LBR-responsive genes
研究概览
简要总结
This pilot phase I trial studies freeze-dried black raspberries in treating patients with oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat oral cancer
详细描述
PRIMARY OBJECTIVES:
I. To determine the relationship between the length of short-term lyophilized black raspberries (LBR) administration to human oral cancer patients and the modulation, in oral cavity tissues, of a subset of specific genes previously identified by us to be "LBR-responsive" and associated with LBR's chemopreventive activity.
SECONDARY OBJECTIVES:
I. To evaluate the effects of LBR administration in humans on cell proliferation, apoptosis, and angiogenesis in oral cavity tissues using various established biomarkers including Ki-67 or proliferating cell nuclear antigen (PCNA), caspase-3, vascular endothelial growth factor (VEGF) or basic fibroblast growth factor (bFGF).
II. To assess the feasibility of administering lyophilized freeze-dried black raspberries in oral troche form to pre-surgical patients diagnosed with squamous cell carcinoma of the oral cavity (compliance, tolerance, adverse events).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with newly diagnosed, biopsy-proven previously untreated squamous cell carcinoma (SCC) of the oral cavity (stages I - IV); suspected cases of SCC will be allowed if biopsy is performed and results of SCC confirmed on subsequent histopathologic analysis (i.e. frozen section) prior to enrollment and initiation of LBR administration
- •Patients must already be planned for surgical resection of their tumor (prior to being considered eligible for this study)
- •Patients must be able to take nutrition/medications orally
- •No prior history of intolerance or allergy to berry or berry-containing products
排除标准
- •History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
- •Known history of bleeding disorder or patient on systemic anticoagulation therapy (i.e. coumadin, heparin) for purposes of the study biopsy
- •Pregnant women; although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of LBR administration, then LBR will be discontinued and patient will be removed from the study
- •Inability to grant informed consent
- •Patients must not be planning to receive chemotherapy or radiation therapy prior to their surgery or this will affect endpoint analysis and these patients will be excluded from the study
- •Patients taking cyclooxygenase (COX)-I or COX-2 inhibitors, who cannot be taken off the medication due to their clinical condition will be excluded given that these agents may interfere with biomarkers studied
- •Vegetarians will be excluded from the study since we anticipate that this patient population will have difficulty adhering to a low-phenolic diet (restricts basically all plant-based foods)
研究组 & 干预措施
Treatment (chemoprevention)
干预措施: laboratory biomarker analysis (Other)
Treatment (chemoprevention)
干预措施: preventative dietary intervention (Other)
结局指标
主要结局
Relationship between the length of short-term LBR administration to human oral cancer patients and the modulation, in oral cavity tissues, of LBR-responsive genes
时间窗: up to 60 months
Statistical summaries of biopsy to surgery changes in quantitative real-time RT-PCR data made on the log scale (geometric mean of percent changes +/- s.e. expressed as a percentage).Confidence intervals produced and significance of the correlation between real-time RT-PCR values and period of treatment (i.e. time from biopsy to surgery) using Fisher's transformation of Spearman's rank correlation tested. Semi-quantitative IHC analyzed using an ordinal logistic model to determine significance of associations between period of treatment and change in staining from biopsy to surgery.
次要结局
- Evaluate effects of lyophilized freeze-dried black raspberries (LBR) administration in humans on cell proliferation, apoptosis, and angiogenesis in oral cavity tissues using various established biomarkers.(up to 60 months)
- Assess feasibility of administering lyophilized freeze-dried black raspberries in oral troche form to pre-surgical patients diagnosed with squamous cell carcinoma of the oral cavity.(from 7-28 days)
研究者
Amit Agrawal
Principal Investigator
Ohio State University Comprehensive Cancer Center