Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

Korábbi kezelés

• 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 significant loss of gastrointestinal organs due to surgery, except for appendix

Más betegség

• 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
• 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 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

Laborértékek

• Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex)

Egyéb

• Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth)

• 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