Clinical Trial Details

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Study ID OSU-12125
Investigator
Steven Clinton,   Ohio State University Comprehensive Cancer Center
Title Lyophilized Black Raspberry in Treating Patients With Prostate Cancer Undergoing Surgery
Conditions Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions Drug: lyophilized black raspberry lozenge
Other: laboratory biomarker analysis
Dietary Supplement: dietary intervention
Dietary Supplement: dietary intervention
Procedure: therapeutic conventional surgery
Procedure: quality-of-life assessment
Other: questionnaire administration
Phase Phase 1
Purpose This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.
Eligibility Ages Eligible: N/A
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • 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
Exclusion Criteria:
  • 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)
Study Location
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
Contact Elizabeth M. Grainger, PhD
614-293-7817
elizabeth.grainger@osumc.edu
Information objtained from ClinicalTrials.gov, on 9/18/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823562


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