Peripheric NeuropathyNCT07345221
Effect of Hilotherapy in the Management of Symptoms Related to Taxane-Associated Peripheral Neuropathy
A study testing Hilotherapy in people with Peripheric Neuropathy, run by Nuran Ayşen Pamir Aksoy at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheric Neuropathy
- What is being tested?
- Hilotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Jun 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a primary breast cancer diagnosis
- Having received chemotherapy containing taxane compounds due to breast cancer
- Not having been previously diagnosed with peripheral neuropathy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Acibadem Altunizade Hospital
Istanbul
Ayşe Yaramış, +90 555 185 15 13, ayse.yaramis@acibadem.com
- Recruiting
Acibadem Maslak Hospital
Istanbul
Nurullah Bakır, +90 506 068 94 21, nurullah.bakir@live.acibadem.edu.tr
About this study
Official title: 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).
Read the detailed description
Hilotherapy Device Usage
- 30 minutes before chemotherapy, disposable cellulose covers are placed on the patient's clean hands and feet (for hygiene and to prevent contamination)
- The device is set to 12°C for hands and 14°C for feet.
- Sensors are monitored during chemotherapy.
- The hylotherapy application is continued for another 60 minutes after the end of the chemotherapy course.
- 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
- Conditions
- Peripheric Neuropathy
- Being tested
- Hilotherapy
- Keywords
- hilotherapy, peripheric neuropathy, symptom management, pain, comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HilotherapyDevice
Applying hilotherapy device at chemotherapy courses
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Hilotherapy Receives: Device: Hilotherapy |
| Control group | No intervention | Non-hilotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taxan-induced peripheric neuropathy score
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:
- = "Not at all"
- = "A little"
- = "Quite a bit"
- = "Very much" Interpretation Higher total scores (closer to 100) = More severe neuropathy symptoms Lower total scores (closer to 0) = Fewer/milder symptoms
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start4 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheric NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuran Ayşen Pamir Aksoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nuran Ayşen Pamir Aksoy, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345221
- Sponsor's protocol ID
- 2023-13-470
- Status last verified
- Jan 2026
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07345221
- Acronym / sponsor ID
- 2023-13-470
- Conditions
- Peripheric Neuropathy
- Keywords
- hilotherapy, peripheric neuropathy, symptom management, pain, comfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nuran Ayşen Pamir AksoyUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Hilotherapy Device Usage
- 30 minutes before chemotherapy, disposable cellulose covers are placed on the patient's clean hands and feet (for hygiene and to prevent contamination)
- The device is set to 12°C for hands and 14°C for feet.
- Sensors are monitored during chemotherapy.
- The hylotherapy application is continued for another 60 minutes after the end of the chemotherapy course.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: HilotherapyHilotherapy |
| Control group | No intervention | –Non-hilotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a primary breast cancer diagnosis
- Having received chemotherapy containing taxane compounds due to breast cancer
- Not having been previously diagnosed with peripheral neuropathy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HilotherapyApplying hilotherapy device at chemotherapy courses | Device | Study Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hilotherapy in people with Peripheric Neuropathy, run by Nuran Ayşen Pamir Aksoy at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nermin Ocaktan, Assist. Prof. (+90 533 737 33 06, nermin.ocaktan@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.