Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026117
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2001-11-09
Brief Title:
Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCCAM | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068987 | REGISTRY | None | None |