Tight Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Trial to Evaluate the Efficacy of Compression Therapy in Patients With Taxane-based Chemotherapy for Breast and Urogenital Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this study, the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Mamma or Urogenital carcinoma

• first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)

• signed informed consent

• sufficient proficiency in German or English

Locations
Other Locations
Switzerland
University Hospital Zuerich
RECRUITING
Zurich
Contact Information
Primary
Anna Götz, PhD
anna.goetz@usz.ch
+41 43 253
Backup
Antje Koller, PhD
antje.koller@ost.ch
+41 58 257
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-03
Participants
Target number of participants: 114
Treatments
Experimental: Compression group
Participants in the intervention group wear surgical gloves at each taxane administration. The intervention will start 30 minutes before the infusion, continue during the infusion, and last until 30 minutes after the infusion ends. Glove size will be measured on both hands before the first use, following the European standard for medical gloves. The gloves will be worn half a size (0.5) smaller than the appropriate size on both hands. With the help of talcum powder, a second glove of the same size will be worn over the first glove on both hands. After selecting the glove size, the compression strength of the two overlapping gloves will be measured once using a pressure measuring device (PicoPress (c)). The PicoPress(c) device (Microlab Elettronica, Italy) is already in use to measure the pressure of compression bandages. The target range for compression pressure is between 23-32 mmHg (compression class 2) (RAL Deutsches Institut für Gütesicherung und Kennzeichnung e. V., 2008).
Sham_comparator: Control group
Participants in the control group will wear two non-compressing surgical gloves of their appropriate size on both hands during each administration of taxanes. The intervention will begin 30 minutes before the infusion, continue during the infusion, and last until 30 minutes after the infusion ends. After selecting the glove size, the compression strength of the two overlapping gloves will be measured once using a pressure measuring device (PicoPress(c)) to verify the pressure. The target range is below 3 mmHg. Measurements with the pressure sensor will be repeated as needed with gloves half a size larger to ensure a low pressure level of less than 3 mmHg.
Related Therapeutic Areas
Sponsors
Leads: St.Gallen University of Applied Sciences
Collaborators: University of Zurich

This content was sourced from clinicaltrials.gov

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