Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01681823|
Recruitment Status : Recruiting
First Posted : September 10, 2012
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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).|
|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 :||August 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: PectaSol-C Modified Citrus Pectin (MCP)
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681823
|Contact: Daniel Keizman, M.D.||+972 (0)9 747 firstname.lastname@example.org|
|Contact: Moshe Frenkel, M.D.||+972 (0)52 331 email@example.com|
|Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,||Recruiting|
|Contact: Daniel Keizman, M.D. +972 (0)9 747 2714 firstname.lastname@example.org|
|Contact: Noa Rapaport +972 (0)9 747 2695 email@example.com|
|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|