A randomized controlled study of cold therapy (cryotherapy) in the prevention of chemotherapy induced nerve damage in breast and gynaecological cancer patients.
- Conditions
- Chemotherapy induced peripheral neuropathyBreast cancerGynaecological cancerCancer - BreastCancer - Cervical (cervix)Cancer - Ovarian and primary peritonealCancer - Womb (Uterine or endometrial cancer)
- Registration Number
- ACTRN12619000974101
- Lead Sponsor
- Mater Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
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.
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.
11.Any cognitive or communication impairments that may impact the safety of cryotherapy.
12.Planned for scalp cooling for alopecia prevention.
13.Requirement for intravenous cannulation in the hands or feet for delivery of chemotherapy or other therapies that are part of standard of care treatments.
14.Nail adornments which are unable to be removed for cryotherapy e.g. artificial nails, nail enamel, nail decorations (adornments) ; or the patient is unwilling to comply with this requirement.
15.Urinary frequency or incontinence that would make compliance with cryotherapy difficult.
16.Any condition which the treating oncologist would consider would preclude cryotherapy or enrolment in a clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the severity of patient reported neuropathy symptoms using the European Organization for Research and Treatment of Cancer (EORTC-QLQ-CIPN20) quality of life (QOL) questionnaire at baseline, at the completion of taxane chemotherapy, and 6 months following completion of taxane chemotherapy between cryotherapy treated patients and controls.[Baseline,at the end of taxane chemotherapy and at 6 months post completion of taxane chemotherapy.]
- Secondary Outcome Measures
Name Time Method Assess the quality of life using the EORTC QLQ-C30 questionnaire at baseline, at the completion of taxane chemotherapy, and 6 months following completion of taxane chemotherapy between cryotherapy treated patients and controls.<br>[.At baseline, at the completion of taxane chemotherapy,and 6 months following completion of taxane chemotherapy];Assess safety and tolerability of cryotherapy during and after treatment using National Cancer Institute (NCI CTCAE V5.0) grading system of adverse events[At baseline, during taxane chemotherapy, at the completion of taxane chemotherapy and 6 months following the completion of chemotherapy];Compare the incidence of patient self-reporting of falls in the 6 months following completion of taxane chemotherapy in the cryotherapy-treated versus the control groups[At 6 months following the completion of taxane chemotherapy- single assessment]