Viewing Study NCT06642441



Ignite Creation Date: 2024-10-25 @ 8:00 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06642441
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-13

Brief Title: Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation VD on chemotherapy side effects following adjuvant chemotherapy in breast cancer
Detailed Description: This is a parallel group open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation VD in adjuvant chemotherapy in patients with breast cancer Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle In addition vitamin D2 will be given randomly to both groups Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy Primary and secondary study findings and adverse events will be thoroughly evaluated

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