Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

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Basic Trial Information

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

Trial Description


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


  • 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


  • 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



  • 18 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • Not specified


  • Bilirubin no greater than 3 times upper limit of normal (ULN)


  • Calcium less than 1.2 times ULN


  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Concurrent chemotherapy allowed
  • No concurrent participation in a cytotoxic chemotherapy clinical trial

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • 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 Integrative Health (NCCIH)
Charles L. Loprinzi, Study Chair

Link to the current record.
NLM Identifier NCT00026117 processed this data on April 09, 2015

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