ACTRN12619000974101招募中未知
A randomized controlled study of cryotherapy in the prevention of chemotherapy induced peripheral neuropathy in breast and gynaecological cancerpatients.
Mater Medical Research Institute0 个研究点目标入组 64 人开始时间: 2019年7月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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