NCT06541769

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

CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression in Patients Undergoing (Neo-) Adjuvant Chemotherapy for Primary Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-15
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: Germany