Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer
- Determine whether the addition of powdered shark cartilage (BeneFin™) to standard
therapy improves overall survival in patients with advanced colorectal or breast
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Charles L. Loprinzi, MD
United States: Federal Government
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|