Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160901
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-09-08
Brief Title:
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Womens Hospital of the University of Heidelberg
Status:
COMPLETED
Status Verified Date:
2007-03
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:
The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium milk thistle goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients
Detailed Description:
patients were randomized to receive a individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium sodium-selenit 100 microgd milk thistle silibin 280 mgd goldenrod solidago 1680gd and pineapple enzyme bromelaine 3000 FIP unitsd during the first three cycles till 3-5 weeks later b individual nutrition consultation with recommendations for physical activity only and c a leaflet 5-a-day for the control group
Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D
Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D
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