Ignite Creation Date:
2024-05-06 @ 1:11 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01751893
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2012-12-14
Brief Title:
Testing the Effectiveness of Henna on Managing PPE
Sponsor:
Cyprus University of Technology
Organization:
Cyprus University of Technology
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of the Effects of Lawsonia Inermis on Palmar-Plantar Erythrodysesthesia Induced by Capecitabine andor Pegylated Liposomal Doxorubicin
Status:
COMPLETED
Status Verified Date:
2019-10
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 palmar-plantar erythrodysesthesia PPE is the only clinical adverse event that commonly occurs with capecitabine andor pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine andor pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia
Detailed Description:
This will be a randomized double-blind placebo-controlled study with 80 cancer patients that will receive chemotherapy treatment with capecitabine andor pegylated liposomal doxorubicin The selection of potential participants will be based on pre-determined inclusion and exclusion criteria Patients will be randomly allocated either to the treatment group or the placebo group Treatment will be delivered twice a week and assessments will take place at 2 3 4 5 and 6 weeks
The intervention group will receive the application of henna 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 henna 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None