Status:
UNKNOWN
Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
Paclitaxel is a chemotherapy drug that is used to treat breast cancer, one of the most common cancers. It causes two side effects very often - hair-loss and numbness. Until recently, there have been n...
Detailed Description
Paclitaxel is a key chemotherapeutic agent used in the management of common cancers, such as breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) due to paclitaxel is a common dose-limitin...
Eligibility Criteria
Inclusion
- The inclusion criterion for the healthy subjects:
- Age 21-80 years
- Signed informed consent from patient.
- No history of neuropathy
- ECOG 0
- No history of hospitalization in the past 6 months
- The inclusion criteria for the cancer patients:
- Age 21- 80 years.
- Signed informed consent from patient
- Scheduled to receive weekly paclitaxel chemotherapy
- For both healthy subjects and cancer patients:
- Open skin wound or ulcers of the limbs
- A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (see outcome parameters) (Not applicable for healthy subjects)
- History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
Exclusion
Key Trial Info
Start Date :
August 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03248193
Start Date
August 4 2017
End Date
April 30 2020
Last Update
August 14 2017
Active Locations (1)
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1
National University Hospital Singapore
Singapore, Singapore, 119228