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

Recruiting now · Not applicable

Conditions studied: CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer

In brief

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.

Key facts

Study ID

NCT05928429

Run by

Maria Lendorf

People needed

300

Starts

2021-01-15

Expected to finish

2026-11-30

Last updated by the study team

2023-07-03

Who can join

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

You may qualify if…

• Key inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 or 12 doses, PS 0-1

You may not qualify if…

• Peripheral sensory/motor neuropathy, neuralgia or edema of the limb graded >=2 (CTCAE ver 5.0), Patient with Raynaud's symptoms; peripheral arterial ischemia; or any other reasons based on the primary physician's judgment.

Where it is running

• Maria E Lendorf — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.