Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022204
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2001-08-10
Brief Title:
Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Double-Blind Placebo-Controlled Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
Status:
COMPLETED
Status Verified Date:
2007-05
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 Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer
PURPOSE Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer
PURPOSE Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer
Detailed Description:
OBJECTIVES I Determine the effects of vitamin E and pentoxifylline on lymphedema in patients previously treated with radiotherapy for breast cancer II Compare the normal tissue injury and quality of life in patients treated with this regimen vs placebo
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to one of two treatment arms Arm I Patients receive oral vitamin E and oral pentoxifylline twice daily for 6 months Arm II Patients receive oral placebo twice daily for 6 months Quality of life is assessed at baseline and at 3 6 9 and 12 months Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to one of two treatment arms Arm I Patients receive oral vitamin E and oral pentoxifylline twice daily for 6 months Arm II Patients receive oral placebo twice daily for 6 months Quality of life is assessed at baseline and at 3 6 9 and 12 months Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| EU-20050 | None | None | None |
| RM-1597 | None | None | None |