CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression

NCT ID: NCT06541769

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2022-07-15

Brief Summary

The POLAR study is a monocentric, prospective, randomized, 2-arm study designed to evaluate the effectiveness of compression or hypothermia in preventing higher-grade chemotherapy-induced peripheral neuropathy (CIPN) (Grade > 1 according to EORTC) in patients undergoing (neo-)adjuvant chemotherapy with weekly Paclitaxel or Nab-Paclitaxel. In this study, the dominant hand of participants will be either cooled or compressed, while the contralateral hand will serve as a control. The treatment groups will be randomized.

The primary aim of the study is to compare the effectiveness of limb hypothermia versus compression in preventing CIPN. Additionally, the investigators will assess the quality of life and therapy acceptance among the participants in both study arms. Data from the two groups will be collected and compared to determine the most effective intervention for preventing CIPN and to understand the overall impact on patients' well-being and treatment adherence.

Detailed Description

This is a prospective, randomized, two-arm study with the aim of assessing the effectiveness of compression or cooling in preventing higher-grade CIPN (>Grade 2 according to EORTC) during weekly paclitaxel or nab-paclitaxel based (neo-)adjuvant chemotherapy. For this purpose, the dominant hand is either cooled or compressed, depending on the study arm, and the contralateral hand is only observed. The allocation to compression or cooling is done through randomization. In a second step, the effectiveness of cooling should be compared with compression. For this purpose, the data collected from the two study arms will be compared. Furthermore, patient satisfaction and quality of life during therapy will be examined. The primary study endpoint is the difference in moderate and severe polyneuropathy (CTCAE grade ≥ 2) compared between the control hand and the intervention hand within the study arms (extremity with cooling vs. control extremity or extremity with compression vs. control extremity). CIPN is evaluated via CTCAE criteria 4.0 and by the Total Neuropathy Score (TNS; clinical version). In addition, sensorimotor symptoms are documented using EORTC QLQ-CIPN20 questionnaires (see also 3.3).

In a second, hierarchical test, the rate of moderate and severe polyneuropathies is compared between the two intervention arms (cooling vs. compression). The rate of onychodystrophies and onycholysis in both intervention arms (compression and cooling) is documented using CTAE criteria and compared between the intervention arm and the control arm as well as between both patient groups.

In addition, patient satisfaction and acceptance of the intervention are examined. EORTC QLQ-C30 questionnaires are used to document quality of life. Any toxicities during therapy are documented according to the CTCAE criteria 4.0.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Onychodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hypothermia

limb Hypothermia with special hypothermia-gel-gloves of the dominant hand starting 30min before chemotherapy application and ending 30min after. The glove will be changed every 30min to provide constant cooling

Group Type: EXPERIMENTAL

Limb hypothermia

Intervention Type: DEVICE

Limb hypothermia with special gel-gloves

Compression

compression of the dominant hand provided by one-way latex-gloves. The necessary size will be determined after measurement for every Patient individually

Group Type: EXPERIMENTAL

Limb compression

Intervention Type: DEVICE

compression with sterile one way Latex gloves. Size measured for every Patient individually

Interventions

Limb hypothermia

Limb hypothermia with special gel-gloves

Intervention Type: DEVICE

Limb compression

compression with sterile one way Latex gloves. Size measured for every Patient individually

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• all female patients with signed informed consent who are starting with (neo-) adjuvant chemotherapy according to the following protocols:

• 4 x Epirubicin/Cyclophosphamid (EC) q3w, followed by 12 x Paclitaxel weekly or 12x Nab-Paclitaxel (+/- Trastuzumab)
• Paclitaxel or Nab-Paclitaxel weekly without anthracyclines
• Paclitaxel or Nab-Paclitaxel weekly in combination with Carboplatin

Exclusion Criteria

• patients without informed consent
• ECOG-Status > 1
• age under 18 years
• previous chemotherapy
• therapy with SSNRI, SSRI, or tricyclic antidepressants especially duloxetine, gabapentine, pregabaline and amitryptiline.
• known polyneuropathy (e.g. alcoholic PNP, nephrogenic PNP, diabetic PNP etc.)
• Patients having diseases connected to PNP:

• Sjögren-syndrome, sarkoidosis, amyloidneuropathy, Morbus Fabry, HSAN (Hereditary Sensoric and Autonome Neuropathy)
• Guillain-Barré-syndrome, acute intermittent porphyria, critical-illness-PNP
• Vaskulitides, HNPP, diabetic amyotrophy, multifokal motoric neuropathy, Lewis-Sumner-syndrome, borreliosis-neuropathy, Zoster-neuritis, neuralgic shoulder amyotrophy
• Myelopathy, compression of the myelon, syringomyelia, meningomyelitis, Restless-Legs-syndrome
• Sulcus-Ulnaris-syndrome, Loge-de-Guyon-syndrome, Medianus-compression-syndrome, multiple sklerosis, AML, Lupus erythematodes, sklerodermia/systemic sclerosis, Ehlers-Danlos-syndrome, CREST-syndrome, Raynaud-syndrome, cold aglutinin disease, hämatologic neoplasms, diabetes mellitus, chronic alcohol abuse, hepatitis C, known severe kidney disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Laura Michel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Michel, M.D.

Role: STUDY_DIRECTOR

University Hospital Heidelberg

Locations

National Center for Tumor diseases (NCT)

Heidelberg, , Germany

Countries

Germany

References

Michel LL, Schwarz D, Romar P, Feisst M, Hamberger D, Priester A, Kurre E, Klein E, Muller J, Schinkothe T, Weiler M, Smetanay K, Fremd C, Heublein S, Thewes V, Breckwoldt MO, Jager D, Bendszus M, Marme F, Schneeweiss A. Efficacy of Hand Cooling and Compression in Preventing Taxane-Induced Neuropathy: The POLAR Randomized Clinical Trial. JAMA Oncol. 2025 Apr 1;11(4):408-415. doi: 10.1001/jamaoncol.2025.0001.

Reference Type: DERIVED

PMID: 40048176 (View on PubMed)

Other Identifiers

NCT/HD_GYNONC:POLAR

Identifier Type: -

Identifier Source: org_study_id