Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-05 @ 12:01 PM
Study NCT ID:
NCT06541769
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression
Sponsor:
University Hospital Heidelberg
Organization:
Study Overview
Official Title:
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression in Patients Undergoing (Neo-) Adjuvant Chemotherapy for Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLAR
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: