Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy

NCT06627348 | Recruiting DMC

• 1 other identifier: HIPPO
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.

Conditions

Equipment and Supplies

Keywords

Chemo-induced Peripheral Polyneuropathy; Taxan; Hilotherapy

Outcome Measures

Primary Outcomes (1)

• incidence of peripheral polyneuropathy

  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.

  Up to one year after the end of chemotherapy.

Secondary Outcomes (7)

• Changes in the result of electrophysical examinations

  From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.

• Adverse effects of hilotherapy

  Up to one year after the end of chemotherapy.

• Tolerance of chemotherapy

  From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.

• Patient reported Quality of Life

  Up to one year after the end of chemotherapy.

• Residual Symptoms of Chemotherapy-induced polyneuropathy

  Up to one year after the end of chemotherapy.

Study Arms (2)

Hilotherapy

ACTIVE COMPARATOR

Cooling of hands and feet during Taxan-based chemotherapy

Device: Hilotherm ChemoCare

No Cooling

NO INTERVENTION

No cooling of hands and feet during Taxan-based chemotherapy

Interventions

Hilotherm ChemoCare DEVICE

Hilotherapy

Hilotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, Nab-Paclitaxel, Docetaxel) independent of the therapy line
• Taxan- and Platin-naivity
• Sufficient knowledge of the German language to assure an adequat survey of patient's history

You may not qualify if:

• 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 (e.g. 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

Sponsors & Collaborators

• University of Ulm: lead
• Hilotherm: collaborator

Study Sites (1)

University Hospital of Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

Central Study Contacts

Angelina FINK, Dr. med.

CONTACT

+4973150058688; angelina.fink@uniklinik-ulm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Gynecology and Obstetrics

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 4, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

DE (1)