Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

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ClinicalTrials.gov Identifier: NCT00026117

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : July 13, 2016

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

Study Description

Brief Summary:

RATIONALE: Shark cartilage extract may help shrink or slow the growth of colorectal cancer or breast cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in treating patients who have advanced colorectal cancer or advanced breast cancer.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Colorectal Cancer	Drug: BenFin Other: placebo	Phase 3

Detailed Description:

OBJECTIVES:

Determine whether the addition of powdered shark cartilage (BeneFin™) to standard therapy improves overall survival in patients with advanced colorectal or breast cancer.
Determine whether this therapy has any impact on toxicity in these patients.
Determine whether this therapy improves the quality of life in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease type (breast vs colorectal female vs colorectal male), age (49 and under vs 50-69 vs 70 and over), ECOG performance status (0-1 vs 2), baseline quality of life (UNISCALE rating less than 50% vs 50-75% vs more than 75%), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	88 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer
Study Start Date :	August 2001
Actual Primary Completion Date :	September 2006
Actual Study Completion Date :	September 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Shark cartilage extract AE 941

Genetic and Rare Diseases Information Center resources: Breast Cancer, Male

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: BeneFin Patients receive oral shark cartilage (BeneFin™) 3-4 times daily. Treatment continues in the absence of unacceptable toxicity. Quality of life is assessed weekly for 1 month and then monthly thereafter during treatment. Patients are followed every 6 months for 5 years.	Drug: BenFin
placebo Patients receive oral placebo 3-4 times daily. Treatment continues in the absence of unacceptable toxicity. Quality of life is assessed weekly for 1 month and then monthly thereafter during treatment. Patients are followed every 6 months for 5 years.	Other: placebo

Outcome Measures

Primary Outcome Measures :

overall survival [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :

quality of life [ Time Frame: Up to 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Breast or colorectal primary tumor sites
- Considered incurable
Breast cancer patients must have disease progression after at least 2 different chemotherapy regimens (may include chemotherapy given as an adjuvant treatment)

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Male or female

Performance status:

ECOG 0-2

Life expectancy:

More than 3 months

Hepatic:

Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal:

Calcium less than 1.2 times ULN

Other:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy:

Concurrent chemotherapy allowed
No concurrent participation in a cytotoxic chemotherapy clinical trial

Other:

At least 60 days since prior shark cartilage

Contacts and Locations

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): NCT00026117

Locations

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United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CentraCare Health Plaza
Saint Cloud, Minnesota, United States, 56303
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

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Study Chair:	Charles L. Loprinzi, MD	Mayo Clinic

More Information

Publications of Results:

Loprinzi CL, Levitt R, Barton DL, Sloan JA, Atherton PJ, Smith DJ, Dakhil SR, Moore DF Jr, Krook JE, Rowland KM Jr, Mazurczak MA, Berg AR, Kim GP; North Central Cancer Treatment Group. Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer. 2005 Jul 1;104(1):176-82.

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Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT00026117
Other Study ID Numbers:	NCCTG-971151 CDR0000068987 ( Registry Identifier: PDQ (Physician Data Query) ) NCCAM
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	July 13, 2016
Last Verified:	July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:


stage IV colon cancer stage IV breast cancer recurrent breast cancer stage IV rectal cancer	recurrent colon cancer recurrent rectal cancer male breast cancer

Additional relevant MeSH terms:

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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

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