Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
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ClinicalTrials.gov Identifier: NCT00026117 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: July 13, 2016
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Colorectal Cancer | Drug: BenFin Other: placebo | Phase 3 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer |
Study Start Date : | August 2001 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

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. |
Drug: 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. |
Other: placebo |
- overall survival [ Time Frame: Up to 5 years ]
- quality of life [ Time Frame: Up to 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026117
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Minnesota | |
CCOP - Duluth | |
Duluth, Minnesota, United States, 55805 | |
CentraCare Health Plaza | |
Saint Cloud, Minnesota, United States, 56303 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68106 | |
United States, North Dakota | |
Medcenter One Health System | |
Bismarck, North Dakota, United States, 58501 | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
United States, Ohio | |
CCOP - Toledo Community Hospital | |
Toledo, Ohio, United States, 43623-3456 | |
United States, South Dakota | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57104 |
Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
Publications of Results:
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00026117 History of Changes |
Other Study ID Numbers: |
NCCTG-971151 CDR0000068987 ( Registry Identifier: PDQ (Physician Data Query) ) NCCAM |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | July 13, 2016 |
Last Verified: | July 2016 |
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV colon cancer stage IV breast cancer recurrent breast cancer stage IV rectal cancer |
recurrent colon cancer recurrent rectal cancer male breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Colorectal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |