Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
NCT ID: NCT00026117
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2001-08-31
2006-09-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in treating patients who have advanced colorectal cancer or advanced breast cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BeneFin
Patients receive oral shark cartilage (BeneFin™) 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.
BenFin
placebo
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.
placebo
Interventions
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BenFin
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Charles L. Loprinzi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Duluth
Duluth, Minnesota, United States
CentraCare Health Plaza
Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Countries
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References
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Loprinzi CL, Levitt R, Barton DL, Sloan JA, Atherton PJ, Smith DJ, Dakhil SR, Moore DF Jr, Krook JE, Rowland KM Jr, Mazurczak MA, Berg AR, Kim GP; North Central Cancer Treatment Group. Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer. 2005 Jul 1;104(1):176-82. doi: 10.1002/cncr.21107.
Other Identifiers
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CDR0000068987
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCAM
Identifier Type: -
Identifier Source: secondary_id
NCCTG-971151
Identifier Type: -
Identifier Source: org_study_id
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