Prospective Monocentric Study Evaluating Patients' Satisfaction and Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Induced by Taxane or Platinum-based Chemotherapies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration.
研究概览
简要总结
Evaluation of Satisfaction & Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy
详细描述
Peripheral neuropathy (PN) is an adverse event of numerous chemotherapy agents commonly used, including taxanes (paclitaxel, docetaxel) and platinum-based treatments (oxaliplatine, cisplatine, carboplatine).
Taxanes are widely used in breast cancer. Docetaxel and paclitaxel became indispensable during the last decade in metastatic and early stage breast cancer treatment. For platinum-based chemotherapies, oxaliplatine is one of the main molecules used in digestive oncology, particularly in colorectal cancer.
The limiting toxicities of taxanes and platinum-based treatments which can lead to the therapeutic scheme modification (therefore to a potential diminution of efficacy and eventually to treatment stop) are mainly hematologic (neutropenia) and neurological, the most frequent neuro-toxicity event being a PN associated or not to neuropathic pains. The PN induced by chemotherapy can occur prematurely during the treatment course, persist between the treatments' cycles and last a long time after the end of cycles, with an impact on patients' quality of life. Symptoms are mainly sensitive, including pain, paresthesia and hands / foot numbness. These symptoms, as the hematologic toxicity, represent a major limiting factor for the treatment.
According to the ASCO recommendations, there is no effective prophylactic method against the chemo-induced PN. In a retrospective study, the chilled gloves used for preventing the nail lesions during chemotherapy may reduce the incidence of docetaxel-induced PN. Recently, the surgical gloves efficacy against paclitaxel-induced PN has been evaluated prospectively in women presenting a metastatic or early stage breast cancer, with a percentage of grade >=2 NP significantly lower for the hand protected by surgical gloves than the control hand without glove (compression-induced vasoconstriction responsible for a blood flow reduction in the hands and therefore for the local exposure to chemotherapy agents) and a good tolerance.
Chilled gloves, which use the same principle of vasoconstriction through cold, are also used in the current practice for preventing the PN occurrence. However, contrary to surgical gloves, they can be not well tolerated since the very first cycles (intolerance to cold sensation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old
- •Breast cancer requiring a treatment by paclitaxel or colorectal cancer requiring a treatment by oxaliplatine
- •At least 8 chemotherapy cycles planned
- •Able to understand, read and write French language
- •Covered by a social insurance
- •Dated and signed informed consent
排除标准
- •Pre-existing neuropathy or history of neuropathy
- •Psychological, family, sociological or georgraphical condition that may potentially compromise the adherence to study protocol and follow up
- •Cohort 1: Patients presenting a Raynaud's syndrome (contra-indication to cold temperatures)
- •Participation to clinical trial which may interfere with the evaluation of the main endpoints.
- •Pregnant or breastfeeding women
结局指标
主要结局
Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration.
时间窗: At the end of paclitaxel administration (4 to 6 months after inclusion)
Global patient's satisfaction evaluated for each hand using a numeric scale from 0 (very unsatisfied) to 10 (very satisfied)
Cohort 2: Efficacy of compression induced by surgical gloves vs peripheral neuropathies development in patients treated by oxaliplatine after a cumulative dose of 595 mg/m2
时间窗: After the end oxaliplatine administration (4 to 6 months after inclusion)
Percentage of NP grade \>= 2 after a cumulative dose of 595 mg/m2 using NCI-CTCAE v5
次要结局
- Cohort 1: Evaluation of comfort and pain felt with gloves for each hand(At the end of each cycle (each cycle is 7 days))
- Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand(12 months after the end of treatment)
- Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand(At the end of paclitaxel administration (4 to 6 months after inclusion))
- Cohort 2: Evaluation of the global satisfaction concerning surgical gloves wearing, comfort, pain and ease to wear(At the end of oxaliplatine administration (4 to 6 months after inclusion))
- Evaluation of the ease to put on gloves for each hand(At the end of paclitaxel administration (4 to 6 months))
- Cohort 1: Evaluation of the percentabe of onycholysis grade 2 for each hand(At the end of paclitaxel administration (4 to 6 months after inclusion))
- Cohort 1: Evaluation of nurses's preference for the gloves wearing (surgical versus chilled gloves)(At the end of paclitaxel administration (4 to 6 months after inclusion))
- Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand(At the end of oxaliplatine administration (4 to 6 months after inclusion))
- Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand(12 months after the end of treatment.)