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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01681823
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
EcoNugenics

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
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)
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
Study Start Date : June 2013
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Pectin

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

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


Locations
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Israel
Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,
Kfar-Saba, Israel
Sponsors and Collaborators
EcoNugenics
Investigators
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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
Publications:
Azemar M, Hildenbrand B, Haering B, Heim ME, Unger C. Clinical benefit in patients with advanced solid tumors treated with modified citrus pectin: a prospective pilot study. Clin Med: Oncol. 2007;1:73-80.

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Responsible Party: EcoNugenics
ClinicalTrials.gov Identifier: NCT01681823    
Other Study ID Numbers: MMC12192-12CTIL
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Keywords provided by EcoNugenics:
Prostate Cancer
Prostatic Neoplasms
Prostate Specific Antigen
Modified Citrus Pectin
PectaSol-C
Biochemical Relapse
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases