Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 (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.

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

Eligibility 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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

Charles L. Loprinzi

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026117
Information obtained from ClinicalTrials.gov on February 27, 2013

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