Breast Cancer, Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, male breast cancer
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.
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.
Interventions
DRUGBenFin
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | Up to 5 years |
Countries
United States
Outcome results
None listed