- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026117
Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Illinois
-
Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- CCOP - Duluth
-
Saint Cloud, Minnesota, United States, 56303
- CentraCare Health Plaza
-
-
Nebraska
-
Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Medcenter One Health System
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
-
-
Ohio
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
|
Other: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCTG-971151
- CDR0000068987 (Registry Identifier: PDQ (Physician Data Query))
- NCCAM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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