Several new clinical trials have been recently instigated on salvestrols and related synthetic compounds such as flavopiridol and combretastatin. Altogether there are over 100 clinical trials globally. Salvestrol S30 (Resveratrol) is the most widely studied salvestrol and is undergoing 45 separate clinical trials for a range of diseases and to study its cholesterol lowering ability. Salvestrol K50 (Quercetin) is undergoing 19 clinical trials against prostate and colon cancer. Salvestrol T30 is being studied in a single trial against cancer. Over 60 studies of the synthetic salvestrol flavopiridol are ongoing against cancers as diverse as multiple myeloma and leukaemia. Synthetic salvestrol S54 (Combretastatin) is also under current investigation against drug resistant cancers.
Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)
Active Comparator: Quercetin supplement Dietary Supplement: Quercetin supplement
500 mg/d quercetin (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by genistein and placebo supplement.
Other Name: Q-Force Chew
Active Comparator: Genistein supplement Dietary Supplement: Genistein supplement
100 mg/d genistein (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by placebo and quercetin supplement.
Other Name: Q-Force Chew
Placebo Comparator: Placebo Dietary Supplement: Placebo
vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.
Other Name: Q-Force Chew

Detailed Description:
Prostate cancer (PC) is the most frequently occurring cancer in men. Its clinical incidence and mortality rates vary geographically, being much lower in Asia than in Western countries. Notably, latent PCs seem to be equally distributed, thus supporting the hypothesis, that environmental factors may be important in prostate cancer progression. Moreover, epidemiological evidence strongly supports the concept that the incidence of clinical prostate cancer depends on lifestyle factors, mainly related to diet. The isoflavone genistein and the flavonoid quercetin have been identified as likely preventive candidates. The aim of the intended clinical trial is to evaluate the hypothesized effectiveness of polyphenolic phytochemicals with highly purified dietary supplements in patients at high risk of clinical PC and without systemic treatment. This will provide data, which serve as an important pre-requesite for targeted dietary interventions using alternative medicine as preventive measures in men with latent PC.

Sulindac and Plant Compounds in Preventing Colon Cancer
This study has been terminated.
( Study completed )

First Received on November 1, 1999. Last Updated on January 26, 2011 History of Changes
Sponsor: University of Medicine and Dentistry New Jersey
Collaborator: National Cancer Institute (NCI)

Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00003365
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of sulindac may be an effective way to prevent colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may prevent the development of colon cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin, and quercetin in preventing colon cancer.

Condition
Intervention

Colorectal Cancer Dietary Supplement: curcumin
Dietary Supplement: rutin
Drug: quercetin
Drug: sulindac

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Curcumin Sulindac
U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Study Start Date: August 1996
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:
€ Determine the response of the colonic epithelium in normal volunteers at average or above average risk of colon cancer, when given short term treatment with plant phenolics such as curcumin, rutin, and quercetin.
€ Compare the colonic mucosal response to the plant phenolics with their response to sulindac in order to evaluate whether they share common mechanisms for colon cancer chemoprevention.
€ Determine the lowest optimal dose for each of the three plant phenolics that is effective in modulating biomarkers of colon epithelial cell turnover and, therefore, potentially inhibiting colon cancer development.
€ Assess the response of the colonic epithelium to curcumin in volunteers at average risk of colon cancer development.
OUTLINE: This is a randomized, controlled, two part, single institution study. Patients in Part B are randomized by gender.
All patients undergo flexible sigmoidoscopic exam.
€ Part A: Patients, in cohorts of 5-10, receive one of the following five treatments in addition to the control diet: nothing (arm I), oral sulindac twice a day (arm II), oral rutin at 1 of 3 doses twice a day (arms III, IV, and V), oral quercetin at 1 of 3 doses twice a day (arms V, VI, and VII), or at 1 of 3 doses oral curcumin twice a day (arms VIII, IX, and X). Patients are first randomized to the highest doses of rutin, quercetin, and curcumin and then lower doses may be given in order to determine the minimally effective dose. Treatment is continued for 6-10 weeks.
€ Part B: Patients are randomized to receive the control diet only (arm I) or the control diet plus oral curcumin twice a day (arm II) for 6-10 weeks.
Patients are followed every 2 weeks.
PROJECTED ACCRUAL: There will be 130 patients (110 in Part A and 20 in Part B) accrued into this study.

Dietary Bioflavonoid Supplementation for the Prevention of Neoplasia Recurrence in Colon Cancer

First Received on January 24, 2008. Last Updated on February 2, 2012 History of Changes
Sponsor: Dresden University of Technology
Information provided by (Responsible Party): Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00609310
Purpose
Prove the hypothesis that dietary supplementation with bioflavonoids will diminish the recurrence rate of colonic neoplasia, we will implement a clinical trial comparing bioflavonoids and placebo in a double blind randomized clinical trial. To use a standardised supplementation of bioflavonoids, a commercially available preparation (Flavo-Natin®) will be used.

Condition
Intervention
Phase

Colorectal Cancer Dietary Supplement: Flavonoids Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Supplementation With Bioflavonoids for the Prevention of the Recurrence of Neoplasia in Patients With Resected Colorectal Carcinoma

Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
This study has been completed.

First Received on December 17, 2010. Last Updated on April 12, 2012 History of Changes
Sponsor: University of Mississippi Medical Center
Information provided by (Responsible Party): Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01267227
Purpose