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

NCT06832501 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Henna
  • Hand-Foot Syndrome
  • Case-Control Study

Interventions

OTHER

Henna

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.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Berna Kurt, Assistant professor · Hacettepe University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2018-12-15
Completion
2019-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832501 on ClinicalTrials.gov