Effect of Hilotherapy in the Management of Symptoms Related to Taxane-Associated Peripheral Neuropathy

January 9, 2026 updated by: Nuran Ayşen Pamir Aksoy

Effect of Hilotherapy on Quality of Life and Comfort Level in the Management of Symptoms Related to Taxane-Associated Peripheral Neuropathy in Breast Cancer Patients

In this randomized controlled study, it was aimed to determine the effect of hilotherapy on quality of life and comfort level in the management of symptoms related to taxane-associated peripheral neuropathy in patients with breast cancer.

  • The experimental and control group patients will answer the survey questions according to the data collection forms before the first chemotherapy course (To) and will undergo physical examinations by the researcher.
  • In the experimental group, the Hilotherapy device will be connected and initiated 30 min before the chemotherap.
  • The device will continue to cool for another 60 minutes when the chemotherapy ends.
  • Both groups will continue to receive chemotherapy courses at the intervals determined as planned.
  • Hilotherapy will be applied to the experimental group patients during each course according to the study protocol.
  • For both groups, participants will answer the questions according to the data collection forms and will undergo physical examinations by the researcher after the 4th chemotherapy course (T1), 8th chemotherapy course (T2), 12th chemotherapy course (T3) and 4 weeks after the end of chemotherapy (T4).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hilotherapy Device Usage

  1. 30 minutes before chemotherapy, disposable cellulose covers are placed on the patient's clean hands and feet (for hygiene and to prevent contamination)
  2. The device is set to 12°C for hands and 14°C for feet.
  3. Sensors are monitored during chemotherapy.
  4. The hylotherapy application is continued for another 60 minutes after the end of the chemotherapy course.
  5. At the end of the period, the sleeves and disposable covers are removed.

Data Collection Tools of the Study

  • Introductory Information Form (designed by the researchers)
  • "Other Methods Used by the Patient to Prevent Peripheral Neuropathy" Form
  • Hilotherapy Application Data Form
  • LANSS Pain Scale
  • European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)
  • European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Associated Peripheral Neuropathy Scale (EORTC QLQ-CIPN20)
  • General Comfort Scale-Short Form

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a primary breast cancer diagnosis
  • Having received chemotherapy containing taxane compounds due to breast cancer
  • Not having been previously diagnosed with peripheral neuropathy

Exclusion Criteria:

  • Presence of distant metastasis
  • History of psychiatric disorder
  • Diagnosed diseases such as diabetes mellitus, autoimmune disease, megaloblastic anemia, cervical/spinal disc herniation, Raynaud's
  • Active lesions on hands or feet
  • Bleeding/clotting disorder
  • Extremity amputation
  • Any problem that prevents cognitive, emotional and verbal communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Hilotherapy
Device: Hilotherapy
Applying hilotherapy device at chemotherapy courses
No Intervention: Control group
Non-hilotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taxan-induced peripheric neuropathy score
Time Frame: Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo)

Taxan-induced peripheric neuropathy score measured by "European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Related Peripheral Neuropathy Scale (EORTC QLQ-CIPN20)" The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20) is a specific tool for determining TIPN symptoms. This patient-reported questionnaire comprises 20 items that can be divided into 3 subscales (sensory-9 items, motor-8 items, and autonomic-2 items. Item 39 is not included in any subscale and is analyzed separately as a single item). Responses follow a 4-point Likert scale:

  1. = "Not at all"
  2. = "A little"
  3. = "Quite a bit"
  4. = "Very much" Interpretation Higher total scores (closer to 100) = More severe neuropathy symptoms Lower total scores (closer to 0) = Fewer/milder symptoms
Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General comfort level of patients
Time Frame: Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo)
Confort level assessed by "General Comfort Scale Short Form". Is is a condensed version of the original Kolcaba General Comfort Questionnaire, designed to assess a patient's comfort levels across physical, psychospiritual, environmental, and sociocultural domains. The short form includes 28 items and uses a 6-point Likert scale. (1 = Strongly Disagree (least comfort) - 6 = Strongly Agree (most comfort)) Interpretation Higher scores (↑) = Better comfort (e.g., 70-100 = high comfort). Lower scores (↓) = Discomfort or unmet needs (e.g., <50 = significant discomfort).
Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuran Ayşen Pamir Aksoy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 4, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-13-470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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