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

Recruiting now · Not applicable

Conditions studied: Peripheric Neuropathy

In brief

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).

Key facts

Study ID

NCT07345221

Run by

Nuran Ayşen Pamir Aksoy

People needed

60

Starts

2025-06-04

Expected to finish

2026-08-01

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Acibadem Altunizade Hospital — Istanbul, Turkey (Türkiye) (enrolling)
• Acibadem Maslak Hospital — Istanbul, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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