Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA
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|ClinicalTrials.gov Identifier: NCT01681823|
Recruitment Status : Recruiting
First Posted : September 10, 2012
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III, Single-Center, Open Label, Trial Evaluating the Safety and Efficacy of PectaSol-C Modified Citrus Pectin on PSA Kinetics in Prostate Cancer in the Setting of Serial Increases in PSA|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: PectaSol-C Modified Citrus Pectin
Treatment with 4.8 grams PectaSol-C Modified Citrus Pectin three times a day, away from meals for six months.
Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)
Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).
- Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels. [ Time Frame: 6 month endpoint. ]PSA doubling time increase will be used to show effectiveness of the Modified Citrus pectin (MCP).
- An assessment of adverse side effects due to Modified Citrus Pectin (MCP). [ Time Frame: 6 month endpoint. ]Patient tolerability of MCP will be assessed by comparing the results of weekly self-assessment diaries with baseline assessments.
- Blood Serum Analysis (Galectin-3, C-Reactive Protein, Lipid Panels) [ Time Frame: 6 month endpoint. ]At baseline (0 month), and end of study (6 month): Blood draw for serum levels of galectin-3, C-reactive protein, and lipid panel.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681823
|Contact: Daniel Keizman, M.D.||+972 (0)9 747 email@example.com|
|Contact: Moshe Frenkel, M.D.||+972 (0)52 331 firstname.lastname@example.org|
|Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,||Recruiting|
|Contact: Daniel Keizman, M.D. +972 (0)9 747 2714 email@example.com|
|Contact: Sharon Berkley +972 (0)9 747 2101 firstname.lastname@example.org|
|Principal Investigator: Daniel Keizman, M.D.|
|Principal Investigator:||Daniel Keizman, MD||Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center|
|Study Director:||Isaac Eliaz, MD, LAc, MS||Amitabha Medical Clinic and Healing Center|
|Study Chair:||Moshe Frenkel, MD||Clinical Associate Professor, University of Texas|