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NCT Number: NCT06627348

Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location status: Recruiting

Location contact

Angelina Fink, Dr. med.

CONTACT

[email protected]

+4973150058688

About this study

In this trial, patients receiving Taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17°C. Randomization will be 50:50.

if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy.

To assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen.

Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, 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

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 (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

Treatment and study plan

Hilotherm ChemoCare

Device

Hilotherapy

Primary outcomes

  1. incidence of peripheral polyneuropathy

    Time frame: Up to one year after the end of chemotherapy.

    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.

Secondary outcomes

  1. Changes in the result of electrophysical examinations

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

    Changes in the result of electrophysical examinations before and after chemotherapy.

  2. Adverse effects of hilotherapy

    Time frame: Up to one year after the end of chemotherapy.

    Adverse effects of hilotherapy documented as any adverse event.

  3. Tolerance of chemotherapy

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

    Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy.

  4. Patient reported Quality of Life

    Time frame: Up to one year after the end of chemotherapy.

    Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire

  5. Residual Symptoms of Chemotherapy-induced polyneuropathy

    Time frame: Up to one year after the end of chemotherapy.

    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.

  6. Subjective extent of CIPN

    Time frame: Up to one year after the end of chemotherapy.

    Subjective extent of CIPN as measured with the EORTC QLQ-CIPN20 (quality of life questionnaire regarding chemotherapy-induced peripheral neuropathy with 20 questins) questionnaire.

    The qustionnaire consits of 20 items on 3 scales. The minimum is 0, the maximum is 100 points. The higher the score, the worse the CIPN.

  7. Acceptance of hilotherapy

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

    Acceptance of hilotherapy measured as the amount of patients that have to stop local cold application during a session (up to 5 minutes) or terminate earlier or stop the treament completely for the rest of chemotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelina FINK, Dr. med.

CONTACT

[email protected]

+4973150058688

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • Hilotherm

Registry information

Official study title

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 Regimen

Acronym: HiPPo

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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