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 : Completed
First Posted : September 10, 2012
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual 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|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
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
|Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,|
|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|