Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

Basic Trial Information

Objectives

1. Determine whether the addition of powdered shark cartilage (BeneFin™) to standard therapy improves overall survival in patients with advanced colorectal or breast cancer.
2. Determine whether this therapy has any impact on toxicity in these patients.
3. Determine whether this therapy improves the quality of life in these patients.

Entry Criteria

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)
• Hormone receptor status:
  • Not specified

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

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

Expected Enrollment

A total of 600 patients (300 per treatment arm) will be accrued for this study within 24 months.

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 (BeneFin™) 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.

Loprinzi CL, Levitt R, Barton DL, et al.: Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer 104 (1): 176-82, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-284-8964 Email: cloprinzi@mayo.edu

Registry Information
Official Title		Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer
Trial Start Date		2001-08-31
Trial Completion Date		2006-09-30
Registered in ClinicalTrials.gov		NCT00026117
Date Submitted to PDQ		2001-08-30
Information Last Verified		2003-02-26
NCI Grant/Contract Number		CA25224

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