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

RECRUITINGN/ASponsored by Maria Lendorf
Actively Recruiting
PhaseN/A
SponsorMaria Lendorf
Started2021-01-15
Est. completion2023-11-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05928429

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

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

Exclusion Criteria:

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.

Conditions3

Breast CancerCIPN - Chemotherapy-Induced Peripheral NeuropathyCancer

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