Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02625415
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2015-12-05
Brief Title:
The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia
Sponsor:
Cyprus University of Technology
Organization:
Cyprus University of Technology
Study Overview
Official Title:
A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
Status:
COMPLETED
Status Verified Date:
2018-08
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:
HFSB6
Brief Summary:
The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia Hand foot syndrome
Detailed Description:
This will be a randomized double-blind placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine andor pegylated liposomal doxorubicin The selection of potential participants will be based on inclusion and exclusion criteria Patients will be randomly allocated either to the treatment group or the placebo group Treatment will be delivered daily tds and assessments will take place at 0 1 2 3 and 4 weeks
The intervention group will receive the application of topical vitamin B6 cream to the hands andor feet of the patients and the control group will receive the placebo
At both baseline and follow-up patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia the Quality of Life the need for dose-limiting due to PPE and Pain intensity using standardized rating scales Data will be analysed with inferential and descriptive statistics
The intervention group will receive the application of topical vitamin B6 cream to the hands andor feet of the patients and the control group will receive the placebo
At both baseline and follow-up patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia the Quality of Life the need for dose-limiting due to PPE and Pain intensity using standardized rating scales Data will be analysed with inferential and descriptive statistics
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