NCT00026117

Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BenFin
OTHER	placebo

Timeline

• Start date: 2001-08-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2016-07-13

Locations

16 sites across 1 country: United States