Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborators:	National Cancer Institute (NCI) National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00026117

Purpose

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	Intervention	Phase
Breast Cancer Colorectal Cancer	Drug: shark cartilage	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer

Drug Information available for: Shark cartilage extract AE 941 Benefin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	August 2001
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

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.

Arm I: Patients receive oral shark cartilage (BeneFin™) 3-4 times daily.
Arm II: 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.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 24 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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)
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Male or female

Menopausal status:

Not specified

Performance status:

ECOG 0-2

Life expectancy:

More than 3 months

Hematopoietic:

Not specified

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:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics
Concurrent chemotherapy allowed
No concurrent participation in a cytotoxic chemotherapy clinical trial

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

At least 60 days since prior shark cartilage

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026117

Locations

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

North Central Cancer Treatment Group

National Cancer Institute (NCI)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Study Chair:

Charles L. Loprinzi, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00026117 History of Changes
Other Study ID Numbers:	CDR0000068987, NCCTG-971151, NCCAM
Study First Received:	November 9, 2001
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms

Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on February 09, 2012