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

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

Overview

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

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

Interventions

• Device Hilotherapy
  Applying hilotherapy device at chemotherapy courses

Primary outcome measures

• 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 2 centers

• Acibadem Altunizade Hospital — Istanbul
• Acibadem Maslak Hospital — Istanbul

Identifiers

NCT: NCT07345221 · 2023-13-470

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗