A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Compliance of daily consumption of tangerine tomato juice or red tomato juice
研究概览
简要总结
This randomized pilot clinical trial compares tangerine and red tomato juice in treating patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found in tomatoes, may help prevent normal cells from transforming into cancer cells in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To conduct a randomized, three-arm pilot clinical trial to determine compliance and safety of daily consumption of tangerine tomato juice or red tomato juice.
SECONDARY OBJECTIVES:
I. To quantify total carotenoids, total lycopene (LYC), cis-LYC, trans-LYC, phytoene, phytofluene, and lycopene metabolites in plasma and prostate tissue in the three groups of men.
II. To evaluate serum biomarkers related to prostate carcinogenesis, including those previously impacted by tomato phytochemicals (testosterone, sex hormone-binding protein [SHBP], insulin-like growth factor [IGF]-I, IGF-binding protein [BP]3, vascular endothelial growth factor [VEGF], and a panel of anti-inflammatory cytokines) by validated assays.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have biopsy proven carcinoma of the prostate
- •Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- •Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Not currently be taking tomato carotenoid dietary supplements or "alternative" products (e.g., lycopene supplements, Lyc-O-Mato, saw palmetto); vitamin A and beta-carotene supplements are allowed
- •Not be allergic to tomatoes or tomato products
- •Have plasma total cholesterol < 200 mg/dL
- •Plasma triglycerides < 200 mg/dL
- •Have blood urea nitrogen and serum creatinine (BUN/Cr) without clinically significant abnormalities after review by the study physicians
- •Liver enzymes without clinically significant abnormalities after review by the study physicians
- •Complete blood count (CBC) without clinically significant abnormalities after review by the study physicians
- •Prothrombin time (PT) without clinically significant abnormalities after review by the study physicians
- •Partial thromboplastin time (PTT) without clinically significant abnormalities after review by the study physicians
- •International normalized ratio (INR) without clinically significant abnormalities after review by the study physicians
- •Voluntarily agree to participate and sign an informed consent document
- •Agree to have prostate biopsy blocks provided to the study for evaluation
- •Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
- •Agree to follow a low lycopene and phytoene diet
排除标准
- •Have an active malignancy other than prostate cancer that requires therapy
- •Have a prostate biopsy with less than 5% cancer involvement
- •Have a history of traumatic or surgical castration
- •Have plasma total cholesterol > 200 mg/dL
- •Have plasma triglycerides > 200 mg/dL
- •Have a history of uncontrolled pituitary hormone diseases that currently require varying doses of supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring varying doses of hormone administration with the exception of diabetes and osteoporosis
- •Are planning to start certain medications after the trial enrollment; no new finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing new prescription medications for urinary outlet obstructive symptoms will result in discontinuing participation in this study; the use of new non-prescription substances to improve urinary tract symptoms will also result in discontinuing participation (i.e. saw palmetto, other herbal, alternative products); men who are currently taking finasteride or medications (meds) for urinary outlet obstructive symptoms may enroll in the study as long as there is no plan to change the dose in the weeks prior to surgery
- •Have a known allergy to tomatoes or have never consumed tomatoes
- •Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
- •Have significant loss of gastrointestinal organs, except for appendix, due to surgery
- •Have altered immunity such as autoimmune disorders, clinically significant anemia, hemophilia, and blood dyscrasias
研究组 & 干预措施
Group I (control, no juice)
Patients consume no tomato juice.
Group II (tangerine tomato juice)
Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
干预措施: dietary intervention (tangerine tomato juice) (Dietary Supplement)
Group II (tangerine tomato juice)
Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
干预措施: questionnaire administration (Other)
Group II (tangerine tomato juice)
Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
干预措施: Correlative studies (Other)
Group III (red tomato juice)
Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
干预措施: dietary intervention (red tomato juice) (Dietary Supplement)
Group III (red tomato juice)
Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
干预措施: questionnaire administration (Other)
Group III (red tomato juice)
Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
干预措施: Correlative studies (Other)
结局指标
主要结局
Compliance of daily consumption of tangerine tomato juice or red tomato juice
时间窗: Up to time of surgery
Incidence of toxicity
时间窗: Up to time of surgery
Differences in carotenoid levels of biological samples between groups
时间窗: Up to time of surgery
Linear regression analysis will be used to examine differences in carotenoid levels of biological samples between groups.
次要结局
- Change in histopathologic markers between the treatment groups(Baseline to time of surgery)
- Change in immunohistochemical markers between the treatment groups(Baseline to time of surgery)
研究者
Steven Clinton
Professor of Internal Medicine
Ohio State University Comprehensive Cancer Center