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

NCT06541769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2024-08-07

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy
  • Onychodystrophy

Interventions

DEVICE

Limb hypothermia

Limb hypothermia with special gel-gloves

DEVICE

Limb compression

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

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Laura Michel, M.D. · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2022-07-15
Completion
2022-07-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541769 on ClinicalTrials.gov