Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Colorectal Cancer

Treatments: Other: placebo; Drug: BenFin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00026117

CDR0000068987 (Registry Identifier)

NCCAM

NCCTG-971151

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

BeneFin

Experimental group

Description:

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.

Treatment:

Drug: BenFin

placebo

Other group

Description:

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.

Treatment:

Other: placebo