Clinical trial · Interventional
Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy
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
NCT06464536CI-TRIAL-00089852ComPrendorecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Taxane-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Compression group
- description
- 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).
- interventionNames
- Other: Compression
- type
- SHAM_COMPARATOR
- label
- Control group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.