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

NCT07345221 | Recruiting

• 1 other identifier: 2023-13-470
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

• 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).

Conditions

Peripheric Neuropathy

Keywords

hilotherapy; peripheric neuropathy; symptom management; pain; comfort

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (1)

• General comfort level of patients

  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)

Study Arms (2)

Study Group

EXPERIMENTAL

Hilotherapy

Device: Hilotherapy

Control group

NO INTERVENTION

Non-hilotherapy

Interventions

Hilotherapy DEVICE

Applying hilotherapy device at chemotherapy courses

Study Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuran Ayşen Pamir Aksoy: lead

Study Sites (2)

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nermin Ocaktan, Assist. Prof.

CONTACT

+90 533 737 33 06; nermin.ocaktan@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: January 15, 2026
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

TU (2)