Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Nail Assessment Scale
研究概览
简要总结
The study compares three strategies to prevent/minimise nail problems occuring in women, with breast cancer, undergoing Taxane chemotherapy. The strategies are: application of nail polish and normal care; application of Onicolife drops and normal care and; normal care only.
详细描述
This protocol outlines a proposal to investigate whether the use of a dark-coloured nail polish or OnicoLife nail drops, compared to standard care, from commencement of taxane based chemotherapy until three months after completion, is effective in preventing or minimising chemotherapy-induced nail problems.
In the UK, taxane based chemotherapy is used within neo-adjuvant, adjuvant and metastatic settings. Taxotere (docetaxel) is provided in an neo-adjuvant and adjuvant setting every three weeks, taxol (paclitaxel) and taxotere are provided in the metastatic setting either weekly or three weekly.
Taxane based chemotherapy with Taxotere has been shown to improve progression-free, disease free and overall survival in the metastatic setting. TACT, a large phase III adjuvant, open-label randomised controlled trial of sequential taxotere following anthracycline chemotherapy did not show any overall gain from the addition of Docetaxel to standard anthracycline chemotherapy. There are many common side effects associated with chemotherapy such as nausea and vomiting, alopecia and neutropenia but with correct management, these are generally tolerated. There is evidence that while taxane chemotherapy improves clinical response and reduces troublesome side effects such as nausea and vomiting, it is also demonstrated to result in more nail toxicity/ changes than AC (adriamycin-cyclophosamide) therapy (92% versus 32% respectively).
It has been suggested that nail problems associated with chemotherapy are under reported in terms of the incidence and severity. Evidence of chemotherapy-induced nail changes was found in studies that involved randomisation to taxane or non-taxane-containing regimens and /or combination therapy.
Case study reports in oncology journals also highlighted nail toxicity and abnormalities following treatment with taxane therapy and associated challenges with continuation of therapy in breast cancer and patients with lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over the age of 18 years who have been diagnosed with a breast cancer.
- •must be receiving adjuvant or neo-adjuvant Taxotere chemotherapy for breast cancer.
- •participants must be fluent English speakers to be eligible to take part, as there are no resources or additional funding for translators or interpreting services.
- •Participants must provide informed consent.
排除标准
- •Male patients with a diagnosis of breast cancer
- •Patients who are non-fluent English speakers
- •Patients with a known hypersensitivity reaction to nail/ relevant cosmetic products
- •Previous treatment with taxane chemotherapy with the last two years
- •Patients with only one upper limb.
- •Patients with a neurological deficit to the upper limb (eg, stroke affecting one side)
结局指标
主要结局
Nail Assessment Scale
时间窗: 6 months
Evaluate nail interventions (nail polish + standard care Vs Onicolife drops + standard care Vs Standard Care only) that may prevent or minimise the occurrence and severity of nail problems measured using the NToX-G12 (Nail Assessment Scale).
Adverse Events
时间窗: 6 months
Evaluate nail interventions (nail polish + standard care Vs Onicolife drops + standard care Vs Standard Care only) that may prevent or minimise the occurrence and severity of nail problems measured using Common Terminology Criteria for Adverse Events v3.0 (CTC-AE v3).
次要结局
- Quality of Life-nail grade severity relationship(6 months)
- Quality of Life - NToX-QoL Health related quality of life questionnaire(6 months)
- Quality of Life - EQ-5D-5L Health related quality of life questionnaire(6 months)