Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05928429

Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer

Led by Maria Lendorf · Updated on 2023-07-03

300

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

Sponsors

M

Maria Lendorf

Lead Sponsor

D

Danish Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.

CONDITIONS

Official Title

Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 or 12 doses
  • Performance status 0-1
Not Eligible

You will not qualify if you...

  • Peripheral sensory or motor neuropathy, neuralgia, or limb swelling graded 2 or higher (CTCAE ver 5.0)
  • Patients with Raynaud's symptoms
  • Patients with peripheral arterial ischemia
  • Any other exclusion based on the primary physician's judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Maria E Lendorf

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

M

Maria E Lendorf, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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