Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer; Colorectal Cancer
• Interventions: Other: placebo; Drug: BenFin

• Registration Number: NCT00026117
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2001-11-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	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.
BeneFin	BenFin	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.

Primary Outcome Measures

Name	Time	Method
overall survival	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
quality of life	Up to 5 years

Trial Locations

Locations (16)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States

CCOP - Duluth; 🇺🇸 Duluth, Minnesota, United States

Medcenter One Health System; 🇺🇸 Bismarck, North Dakota, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Merit Care Hospital; 🇺🇸 Fargo, North Dakota, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CentraCare Health Plaza; 🇺🇸 Saint Cloud, Minnesota, United States

CCOP - Toledo Community Hospital; 🇺🇸 Toledo, Ohio, United States