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

Nuran Ayşen Pamir Aksoy

Status: Enrolling

Conditions: Peripheric Neuropathy

Treatments: Device: Hilotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07345221

2023-13-470

Details and patient eligibility

About

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).

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Study Group

Experimental group

Description:

Hilotherapy

Treatment:

Device: Hilotherapy

Control group

No Intervention group

Description:

Non-hilotherapy