Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer



Status:Completed
Conditions:Breast Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:August 2001
End Date:September 2006

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Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer

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.

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.

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
We found this trial at
16
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Peoria, IL
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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Bismarck, North Dakota 58501
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Bismarck, ND
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Cedar Rapids, Iowa 52403
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Cedar Rapids, IA
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Duluth, MN
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Fargo, North Dakota 58122
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Fargo, ND
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Omaha, NE
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Rapid City, SD
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Saint Cloud, Minnesota 56303
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Saint Cloud, MN
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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Sioux City, Iowa 51101
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Sioux City, IA
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Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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Toledo, OH
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Urbana, IL
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Wichita, Kansas 67214
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Wichita, KS
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