Status:
UNKNOWN
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Lead Sponsor:
National Cancer Centre, Singapore
Collaborating Sponsors:
Terry Fox Foundation
Duke-NUS Academic Medicine Research Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The trial will be preceded by a pilot phase study in 5 patients. This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing ...
Eligibility Criteria
Inclusion
- Provision of written informed consent prior to any study specific procedures.
- Age ≥ 21 years old
- Patients with histologically confirmed early or locally advanced breast cancer
- Must be receiving 12x weekly sessions of paclitaxel as part of their adjuvant or neo-adjuvant chemotherapy
- Must have routine chemotherapy lab investigations as per institutional practice
- Concurrent use of Trastuzumab and/or Pertuzumab for cerbB-2 positive patients as per institutional practice is allowed
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Exclusion
- Patients diagnosed with pre-existing or history of peripheral neuropathy (regardless of cause)
- Patients with history of Raynaud's disease
- Prior use of taxane-based chemotherapy
- Concurrent use of other neuro-toxic chemotherapy with paclitaxel
- Patients who have had any axillary clearance surgery and without a central venous access device for chemotherapy administration
- Patients with any severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03429972
Start Date
September 1 2016
End Date
June 1 2020
Last Update
March 14 2018
Active Locations (1)
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1
National Cancer Centre Singapore
Singapore, Singapore, 169610