Trial record 1 of 2 for:    PectaSol
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Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by EcoNugenics
Sponsor:
Information provided by (Responsible Party):
EcoNugenics
ClinicalTrials.gov Identifier:
NCT01681823
First received: September 6, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

To determine if the oral administration of PectaSol-C Modified Citrus Pectin (MCP) is effective at improving Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels. Also, documentation of any side effects or benefits within parameter of the study is included.


Condition Intervention Phase
Prostatic Neoplasms
Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by EcoNugenics:

Primary Outcome Measures:
  • Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels. [ Time Frame: 6 month endpoint. ] [ Designated as safety issue: No ]
    PSA doubling time increase will be used to show effectiveness of the Modified Citrus pectin (MCP).


Secondary Outcome Measures:
  • An assessment of adverse side effects due to Modified Citrus Pectin (MCP). [ Time Frame: 6 month endpoint. ] [ Designated as safety issue: Yes ]
    Patient tolerability of MCP will be assessed by comparing the results of weekly self-assessment diaries with baseline assessments.


Other Outcome Measures:
  • Blood Serum Analysis (Galectin-3, C-Reactive Protein, Lipid Panels) [ Time Frame: 6 month endpoint. ] [ Designated as safety issue: No ]
    At baseline (0 month), and end of study (6 month): Blood draw for serum levels of galectin-3, C-reactive protein, and lipid panel.


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented PC post local therapy with undetectable Prostate Specific Antigen (PSA), and biochemical relapse (defined as post-surgery PSA > 0.2 ng/ml; post-radiation > nadir +2 ng/ml, the PSA nadir is the lowest PSA reading achieved after treatment), with linear progression of at least 3 PSA tests in at least 3 months before the commencement of the trial.
  • All patients must have negative bone scan and CT scan for the chest-abdomen-pelvis within 2 weeks prior to study initiation.

Exclusion Criteria:

  • Psychological, familial, sociological or geographical conditions that may interfere with compliance with the study or prevent completion or compliance of protocol.
  • Other severe or poorly controlled medical condition(s).
  • Known allergies to any of the ingredients.
  • Hormonal therapy or other therapy for PC in the last 3 months.
  • Positive bone scan or CT scan of the chest-abdomen-pelvis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681823

Contacts
Contact: Daniel Keizman, M.D. +972 (0)9 747 2714 danielkeizman@gmail.com
Contact: Moshe Frenkel, M.D. +972 (0)52 331 1255 office@moshefrenkelmd.com

Locations
Israel
Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59, Recruiting
Kfar-Saba, Israel
Contact: Daniel Keizman, M.D.    +972 (0)9 747 2714    danielkeizman@gmail.com   
Contact: Sharon Berkley    +972 (0)9 747 2101    sharon.berkley@clalit.org.il   
Principal Investigator: Daniel Keizman, M.D.         
Sponsors and Collaborators
EcoNugenics
Investigators
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
  More Information

Publications:

Responsible Party: EcoNugenics
ClinicalTrials.gov Identifier: NCT01681823     History of Changes
Other Study ID Numbers: MMC12192-12CTIL
Study First Received: September 6, 2012
Last Updated: March 31, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by EcoNugenics:
Prostate Cancer
Prostatic Neoplasms
Prostate Specific Antigen
Modified Citrus Pectin
PectaSol-C
Biochemical Relapse

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Pectin
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014