Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer

Conditions
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Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Drug: BenFin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeneFin<br>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. | Drug: BenFin<br> <br> |
| Other: placebo<br>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. | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, male breast cancer