|
Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer Clinical research trials and Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer. Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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 Stage 4 Colon Cancer Studies:
1. Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
2. Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
3. Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum
4. Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
5. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Minnesota Clinical Trials
Other St. Cloud Clinical Trials
Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
|
|
|
|
|
|
|
|
