Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer
Recruiting · NCT05928429 · Interventional (participants receive a specific treatment) · Lead sponsor: Maria Lendorf
View the official record on ClinicalTrials.gov →Interventions studied
Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Maria E Lendorf - Copenhagen, Denmark