Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Maria E Lendorf
Copenhagen, Denmark, 2100
Actively Recruiting
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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