Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy

NCT06464536 | Recruiting

• 1 other identifier: St.GallenU
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Taxane-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• peripheral polyneuropathy

  measured with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grades 0-4 : 0=none, 1=Asymptomatic; clinical or diagnostic observations only, 2=Moderate symptoms; limiting instrumental ADL; 3=Severe symptoms; limiting self care ADL; 4=Life-threatening consequences; urgent intervention indicated (i.e., higher scores meaning worse symptoms)

  at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)

Secondary Outcomes (4)

• peripheral polyneuropathy patient reported outcome

  at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)

• comfort of compression therapy

  at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)

• adherence with compression therapy

  at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)

• Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar)

  at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)

Study Arms (2)

Compression group

EXPERIMENTAL

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).

Other: Compression

Control group

SHAM COMPARATOR

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.

Other: Compression

Interventions

Compression OTHER

conventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands

Also known as: Compression with surgical gloves

Compression group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mamma or Urogenital carcinoma
• first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)
• signed informed consent
• sufficient proficiency in German or English

You may not qualify if:

• other therapy that could have caused peripheral neuropathy within the last 24 months (Taxane, Platin, Vincaalkaloids, etc.)
• History of neuropathy such as Raynaud's phenomenon, fibromyalgia and diabetic polyneuropathy
• Use of polyneuropathy medications including duloxetine; gabapentin/pregabalin; topical amitriptyline, ketamine, baclofen; oral cannabinoids; tricyclic antidepressants; and ganglioside monosialic acid
• such impaired cognition that prevents participation in the study according to the assessment of the caregivers

Sponsors & Collaborators

• St.Gallen University of Applied Sciences: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zuerich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Interventions

Gloves, Surgical

Intervention Hierarchy (Ancestors)

Gloves, Protective; Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Surgical Attire; Surgical Equipment; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Anna Götz, PhD

  USZ

  PRINCIPAL INVESTIGATOR

• Antje Koller, PhD

  St.Gallen University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Götz, PhD

CONTACT

+41 43 253; anna.goetz@usz.ch

Antje Koller, PhD

CONTACT

+41 58 257; antje.koller@ost.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients will wear surgical gloves, patients in the control group will wear gloves of the correct size with a pressure less than 3 mmHg
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 18, 2024
• Study Start: February 3, 2025
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CH (1)