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Clinical Trials (PDQ®)

Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overNCI, OtherCDR0000068987
NCCTG-971151, NCCAM, NCT00026117

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

National Cancer Institute

National Center for Complementary and Alternative Medicine

Charles L. LoprinziStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026117
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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