Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer
Launched by MARIA LENDORF · Jun 23, 2023
Trial Information
Current as of July 02, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of cryotherapy, which involves applying cold temperatures to the body, to see if it can help prevent nerve damage caused by a common chemotherapy drug called paclitaxel in patients with early-stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) can cause uncomfortable symptoms like numbness, tingling, or pain in the hands and feet, making it a significant concern for patients undergoing treatment. The trial aims to find out if cryotherapy can reduce these side effects and is currently recruiting participants.
To be eligible for the trial, patients should be between 65 and 74 years old, diagnosed with early breast cancer, and scheduled to receive weekly treatments of paclitaxel. However, those with existing nerve problems or certain other medical conditions will not be included. Participants can expect to receive either cryotherapy or standard care during their chemotherapy and will be monitored for any changes in their nerve health. This study could provide valuable information on a new way to help patients manage the side effects of breast cancer treatment.
Gender
ALL
Eligibility criteria
- 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.
About Maria Lendorf
Maria Lendorf is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on ethical practices and regulatory compliance, Maria Lendorf collaborates with leading healthcare professionals and institutions to design and execute clinical trials that explore novel therapies and treatment modalities. The organization emphasizes patient safety and data integrity, aiming to contribute valuable insights to the medical community while fostering a culture of collaboration and excellence in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported