Hilotherapy for prevention of chemotherapy-induced peripheral polyneuropathy - A unicentric, prospective-controlled, randomized clinical trial for comparison of local hilotherapy vs. no therapy to prevent peripheral polyneuropathy during Taxan-based chemotherapy regime

Not Applicable

Recruiting

• Conditions: G62.0; C50.9; C54; C56; C53; Drug-induced polyneuropathy; Breast, unspecified; Malignant neoplasm of corpus uteri; Malignant neoplasm of ovary; Malignant neoplasm of cervix uteri

• Registration Number: DRKS00027242
• Lead Sponsor: niversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

* Written consent for participation in this trail
* Age =18 years
* Female
* Breast or genital cancer of the woman
* Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nac-Paclitaxel) independent of the therapy line
* Taxan- and Platin-naivity
* Sufficient knowledge of the German language to assure an adequat survey of patient's history

Exclusion Criteria

* pre-existing peripheral polyneuropathy
• chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy
• Existence of one of the following diseases:
> Diabetes mellitus (of any type)
> neurological diseases that are involving peripheral nerve damage (Multiple Sclerosis, Amytrophic lateral sclerosis, Parkinson's disease)
> chronic pain syndrome
> Cryoglobulinemia
> cold hemagglutination
> cold hives / cold contact hives
> Raynaud's disease
> significant peripheral artery disease
• Lack of knowledge of German
• Males

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS = 11) in patients with gynecologic malignoma that are undergoing Taxan-based chemotherapy regimen with or without a preventive hilotherapy of hands and feet.<br>Study visits will take place at the beginning, in the middle and at the end of the planned chemotherapy regimen.<br>Additionally, two follow-up visits will take place six months and twelve months after the end of chemotherapy.

Secondary Outcome Measures

Name	Time	Method
* Subjective extent of CIPN as measured with the EORTC QLQ-CIPN20 questionnaire.<br>* Changes in the result of electrophysical examinations before and after chemotherapy.<br>* Acceptance of hilotherapy measured as the amount of patients that have to stop local cold application during a session (> 5 miutes) or terminate earlier or stop the treament completely for the rest of chemotherapy.<br>* Adverse effects of hilotherapy documented as any adverse event.<br>* Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy.<br>* Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire<br>* Comparison of the time of regression, cTNS score of persisting symptoms and amount of patients without residues after end of chemotherapy and follow-up between patients with and without preventive hilotherapy.