Dietary Fruit Bioactives and Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
研究概览
简要总结
This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To conduct a dose-escalation study to determine safety and compliance of varying lyophilized black raspberry (LBR) delivery vehicles (a confection and a nectar) at two different doses.
SECONDARY OBJECTIVES:
I. To precisely quantify changes in the content and distribution of black raspberry phytochemicals and their metabolites in the blood and urine and correlate these concentrations with prostate tissue phytochemicals.
II. Measure the ability of black raspberry gummy confection and nectar in altering hormonal patterns (lower insulin-like growth factor-1 [IGF-I], higher insulin-like growth factor-binding protein 3 [IGF-BP3], lower androgens) consistent with reduced prostate carcinogenesis and in parallel with an enhanced capacity to quench reactive oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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 taking berry dietary supplements, or "alternative" products (Acai berry, pomegranate, black raspberry, Optiberry, Juice Plus)
- •Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits
- •Have liver enzymes within normal limits
- •Have complete blood count (CBC) within normal limits
- •Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits
- •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 controlled polyphenolic and/ or ellagitannin 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 a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis
- •Are taking certain medications; no concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted; the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products)
- •Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products
- •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 due to surgery, except for appendix
- •Have altered immunity such as autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias
- •Have noticeable open lesions in the oral cavity, sores that have not healed for more than 2 months or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips
- •Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth)
- •Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex)
研究组 & 干预措施
Arm I (regular diet)
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm I (regular diet)
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm I (regular diet)
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
Arm II (low polyphenol diet)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm II (low polyphenol diet)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
干预措施: dietary intervention (Dietary Supplement)
Arm II (low polyphenol diet)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm II (low polyphenol diet)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
Arm III (low ellagitannin diet)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm III (low ellagitannin diet)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
干预措施: dietary intervention (Dietary Supplement)
Arm III (low ellagitannin diet)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm III (low ellagitannin diet)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
Arm IV (lower-dose lyophilized black raspberry confection)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy.
干预措施: lyophilized black raspberry confection (Drug)
Arm IV (lower-dose lyophilized black raspberry confection)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm IV (lower-dose lyophilized black raspberry confection)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy.
干预措施: dietary intervention (Dietary Supplement)
Arm IV (lower-dose lyophilized black raspberry confection)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm IV (lower-dose lyophilized black raspberry confection)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
Arm V (higher-dose black raspberry confection)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy.
干预措施: lyophilized black raspberry confection (Drug)
Arm V (higher-dose black raspberry confection)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm V (higher-dose black raspberry confection)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy.
干预措施: dietary intervention (Dietary Supplement)
Arm V (higher-dose black raspberry confection)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm V (higher-dose black raspberry confection)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
Arm VI (lower-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: lyophilized black raspberry confection (Drug)
Arm VI (lower-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm VI (lower-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: dietary intervention (Dietary Supplement)
Arm VI (lower-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm VI (lower-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
Arm VII (higher-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: lyophilized black raspberry confection (Drug)
Arm VII (higher-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm VII (higher-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: dietary intervention (Dietary Supplement)
Arm VII (higher-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: quality-of-life assessment (Procedure)
Arm VII (higher-dose black raspberry nectar)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
时间窗: Up to 30 days after completion of study treatment
Compliance determined by consumption of at least 80% of black raspberries (BRB) and positive tests for urinary berry metabolites
时间窗: Up to 6 weeks
A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.
Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
时间窗: Up to 30 days after completion of study treatment
Adverse events were measured by asking participants at each study visit about any new symptoms which may or may not be related to the intervention. No adverse events were reported from any subjects.
Percentage of Intervention Consumed
时间窗: Up to 6-weeks
A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.
次要结局
- Presence of black raspberry metabolites in the urine collected 24 hours before surgery(Up to 6 weeks)
- Changes in PSA or PSA doubling time(Up to 6 weeks)
- Black Raspberry metabolites levels in the prostate tissue removed at surgery(Up to 6 weeks)
- Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery(24 hours)
- Changes in PSA or PSA Doubling Time(Up to 6 weeks)
- Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery(Up to 6 weeks)
研究者
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center