Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07345221

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

Led by Nuran Ayşen Pamir Aksoy · Updated on 2026-01-15

60

Participants Needed

2

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with primary breast cancer
  • Receiving chemotherapy containing taxane compounds for breast cancer
  • No previous diagnosis of peripheral neuropathy
Not Eligible

You will not qualify if you...

  • Presence of distant metastasis
  • History of psychiatric disorder
  • Diagnosed with diabetes mellitus, autoimmune disease, megaloblastic anemia, cervical or spinal disc herniation, or Raynaud's phenomenon
  • Active wounds or lesions on hands or feet
  • Bleeding or clotting disorder
  • Amputation of limbs
  • Any condition preventing cognitive, emotional, or verbal communication

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

2

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

N

Nermin Ocaktan, Assist. Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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