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Home > "S" Clinical Trials Conditions > Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer  Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
For Condition: stage 4 breast cancer,recurrent rectal cancer,recurrent breast cancer,Stage 4 rectal cancer,stage 4 colon cancer,Male Breast Cancer,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI),National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: 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.
Details: 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 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Breast or colorectal primary tumor sites - Considered incurable - Breast cancer patients must have disease progression after 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesLoprinzi, Study Chair, Mayo Clinic Cancer Center
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Additional Information:
Study ID Numbers: CDR0000068987; NCCAM,NCCTG-971151
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026117
Other Recurrent Rectal Cancer Studies:
1. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
2. Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
3. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
4. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
5. Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
Related Studies:
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Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
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