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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Taxane-induced Peripheral Neuropathy
• Intervention / Treatment: Other: Compression

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of treatment with taxanes. The damage to peripheral nerves leads to pain, numbness, and motor dysfunction, which is very distressing for patients and often results in the reduction of the therapeutic dose of taxanes. Preventive measures are limited, but recent studies show that compression of the hands with tight surgical gloves can significantly reduce the incidence of CIPN. The aim of this randomized controlled trial is to investigate the efficacy of compression therapy in reducing CIPN during taxane-based chemotherapy. The randomized controlled and double-blind study will be conducted at the Comprehensive Cancer Center Zurich (CCCZ) of the University Hospital Zurich from 07/24 to 06/25. Participants will be recruited if they have breast cancer or a urogenital carcinoma and are receiving nab-paclitaxel, paclitaxel, or docetaxel. Exclusion criteria include previous neurotoxic treatment, existing neuropathy, peripheral vascular disease, or the use of medications that affect polyneuropathy. The intervention group will wear surgical gloves with a compression pressure of 23-32 mmHg (equivalent to compression class II) for 30 minutes before, during, and 30 minutes after the infusion. The control group will wear non-compressing gloves with a pressure of less than 3 mmHg. The primary endpoint is the occurrence of moderate to severe CIPN within four therapy cycles, measured according to NCI-CTCAE criteria. Secondary endpoints include patient-reported symptoms and quality of life, assessed by the FACT/COG-NTX questionnaire. Comfort and adherence to the compression therapy will also be evaluated. Participants will be randomized into two groups of 57 each. Data collection and analysis will be conducted according to standardized procedures, and the data will be securely and confidentially stored and managed.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Götz, PhD; Phone Number: 2218 +41 43 253; Email: anna.goetz@usz.ch
• Study Contact Backup: Name: Antje Koller, PhD; Phone Number: 1213 +41 58 257; Email: antje.koller@ost.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • University Hospital Zuerich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Other: Compression; conventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands; Other Names: Compression with surgical gloves
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.	Other: Compression; conventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands; Other Names: Compression with surgical gloves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral polyneuropathy patient reported outcome	measured with the neuropathy Subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group - Neurotoxicity (FACT/COG-NTX), The FACT-NTX subscale comprises 11 5-point ordinal scaled items (0=not at all to 4=very much). The points for each item are totaled and can range from 0=no symptoms to 44=severe symptoms. The participant is counted as a case if the change in the FACT-NTX reaches ≥5 points.	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	comfort will be measured with a 0 to 3 scale (0=not comfortable at all, 3=very comfortable)	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	percentage of time that compression should have been administered	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)	Ordinal 1-item scale, ranging from from 0=never to 4=daily	at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)

Collaborators and Investigators

• Sponsor: St.Gallen University of Applied Sciences
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Anna Götz, PhD, USZ; Principal Investigator: Antje Koller, PhD, St.Gallen University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: St.GallenU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: secondary data analysis are planned to be possible on request, data that may disclose the patients identity will be deleted from the dataset

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No