Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041223
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2002-07-08
Brief Title:
IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Double-Blind Placebo-Controlled Randomized Phase II Trial of IH636 Grape Seed Proanthocyanidin Extract GSPE in Patients With Adverse Effects of High Dose Breast Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2002-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 IH636 grape seed extract may lessen hardening of breast tissue caused by radiation therapy and may help patients live more comfortably
PURPOSE Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer
PURPOSE Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to time since prior radiotherapy Patients are randomized to 1 of 2 arms
Arm I Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months
Arm II Patients receive an oral placebo three times daily for 6 months Patients are followed at 6 months
PROJECTED ACCRUAL A total of 72 patients 48 for arm I and 24 for arm II will be accrued for this study
Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to time since prior radiotherapy Patients are randomized to 1 of 2 arms
Arm I Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months
Arm II Patients receive an oral placebo three times daily for 6 months Patients are followed at 6 months
PROJECTED ACCRUAL A total of 72 patients 48 for arm I and 24 for arm II will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RMNHS-GRAPE-1991 | None | None | None |
| RMNHS-1991 | None | None | None |
| EU-20209 | None | None | None |