RecruitingNot ApplicableNCT07345221

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

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


Sponsor

Nuran Ayşen Pamir Aksoy

Enrollment

60 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

Interventions

DEVICEHilotherapy

Applying hilotherapy device at chemotherapy courses


Locations(2)

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT07345221