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 |
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.
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.
- 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
sites
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
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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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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