ACTRN12619000974101
Recruiting
未知
A randomized controlled study of cryotherapy in the prevention of chemotherapy induced peripheral neuropathy in breast and gynaecological cancerpatients.
Mater Medical Research Institute0 sites64 target enrollmentJuly 9, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chemotherapy induced peripheral neuropathy
- Sponsor
- Mater Medical Research Institute
- Enrollment
- 64
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient with a diagnosis of breast or gynaecological cancer over the age of 18 years scheduled to commence neoadjuvant or adjuvant chemotherapy with either paclitaxel or docetaxel.
- •a. Different schedules of chemotherapy are permitted including paclitaxel 80mg/m2 weekly, dose dense paclitaxel 175mg/m2 two weekly, paclitaxel 175mg/m2 three weekly and docetaxel 75 mg/ m2 three weekly.
- •b. Breast cancer patients are eligible if they are receiving their taxane chemotherapy sequential to an anthracycline based treatment, but as part of a single protocol. Breast cancer patients are eligible if they are receiving concurrent HER2 targeted antibody treatment or carboplatin. Gynaecological cancer patients are eligible if they are receiving concurrent carboplatin chemotherapy.
- •2\. ECOG performance status 0\-1\.
- •3\. Patient willing and able to comply with scheduled trial treatment and plan.
- •4\. Signed, written informed consent.
- •5\. Patient is able to speak, read and write English.
Exclusion Criteria
- •1\.Any history of pre\-existing peripheral neuropathy including diabetic neuropathy, carpal tunnel syndrome, peripheral vascular disease, active deep vein thrombosis or thrombophlebitis, rheumatoid arthritis, Raynaud’s disease, cold agglutinin disease, cold urticaria, cryoglobulinemia, fibromyalgia, haemoglobinopathies or connective tissue disorders.
- •2\.Open skin wound or ulcer in the area intended to receive cryotherapy.
- •3\.Lymphoedema or oedema of the limbs.
- •4\.Any prior chemotherapy exposure.
- •5\.Patient who is planned to receive chemotherapy with cisplatin.
- •6\.Extreme sensitivity to cold.
- •7\.Absence of one or more fingers or toes.
- •8\.History of frostbite.
- •9\.Female who is pregnant or plans to become pregnant during the study.
- •10\.Female who is breast feeding.
Outcomes
Primary Outcomes
Not specified
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