CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Hennaother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06832501
NCT06832501N/ACompleted

Effectiveness of the Henna Application in Patients With Hand-Foot Syndrome: Nested Case-Control Study

Hacettepe University·observational·Posted Feb 18, 2025·Updated Feb 18, 2025

In Brief

An observational study evaluating Henna for Henna and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed Summary

Introduction: There is an explanation that there is a connection between the application of henna and the occurrence of hand-foot syndrome, and the purpose and progression of this interaction. This nested case-control study of participants who underwent capecitabine therapy were breast and colorectal cancer was carried out to prospectively investigate the relationship of hand-foot syndrome with the henna application. Method: Nested Case-Control (NCC) design within a longitudinal observational prospective cohort study in the setting of an oncology clinic. The primary outcome was hand-foot syndrome from in-hospital interviews and medical record reviews. In the data collection process, 84 patients received capecitabine and two patients (1:2) who met the inclusion criteria served as the control group (n=56, who received the test) for each case (n=28). The case and control groups were followed for 12 weeks. HFS-14 Scale and EORTC QLQ-C30 Quality of Life were conducted on the baseline, first follow-up (T1=day 21), and second follow-up (T2=day 63) cycles of chemotherapy. We used a non-parametric signed-rank test to test the median of paired differences.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 18, 2025
Enrollment StartOct 15, 2018
Primary CompletionDec 15, 2018
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 1.4 years ago

Interventions

Hennaother

The day-care unit of the University of Hacettepe's oncology hospital is being trained by educational nurses on the treatment of patients receiving capecitabine a day before the application of chemotherapy. All the patients were questioned about their individual and disease-related characteristics using the Patient Information Form, and The National Cancer Institute common terminology criteria for adverse events - version 4.03 (NCICTCAE v4.03), EORTC C30 Cancer Quality of Life Scale, and The Hand-Foot Syndrome-14 (HFS-14) were used by face-to-face interview technique.On the 21st day and the 63rd day after the first treatment course, patients who developed hand-foot syndrome constituted the case-control group, including patients who applied henna and patients who did not apply henna.