KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 12
- 主要终点
- Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of administration protocol
研究概览
简要总结
The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation...) and administration protocol (route, posology, duration, administration sequence, premedication).
The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression.
In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology.
详细描述
Almost 382,000 new cancers have been diagnosed in France in 2018. Regular progresses in their management have improved the overall survival of patients, sometimes with sequelae that may be particularly painful. Thus for 20 to 45% of patients treated for breast cancer, pain persists 5 years later.
If remission is a regularly reached target, cancer was also the cause of 157,000 deaths in 2018 in France, preceded by months or years of progression of a chronic disease that regularly causes pain. Pain during cancer (chronic cancer pain for CIM-11) remains a frequent symptom, and its prevalence has slightly changed during the last 20 years.
In the European EPIC study, carried out in 2006, 76% of the cancer patients (and 62% of French patients) presented moderate to severe pains linked to cancer, daily for more than half of them.
Even when identified, chronic cancer pain is still under-treated in 25 to 60% of cases worldwide, including in the most developed countries.
When well-managed, pain's management now allows the relief of almost 80% of patients. Pain's management is based in particular on a precise and adapted use of the different opioids through different routes of administration (oral, transdermal, trans-mucosal, parenteral, etc.).
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
- •Patient at least 18 years old at the day of consenting to the study
- •Patient followed for a solid tumour or a hematological malignancy (treated or under treatment)
- •Patient presenting cancer chronic pain or post cancer treatment pain
- •Patient followed by a CLCC's intractable chronic pain consultation or centre
- •Patient with an indication of 1st Ketamine course:
- •Analgesic treatment of cancer chronic pain
- •Analgesic treatment for a post-cancer treatment chronic pain
- •Help for withdrawal from opioid treatment prescribed for a chronic cancer pain
- •Patient not previously treated by Ketamine
- •Patient covered by a medical insurance
- •Patient and/or family did not decline data collection after complete information (information sheet)
排除标准
- •Patient presenting chronic pains not related to cancer or its treatments
- •Patient with a proven psychotic history
- •Patient who is not fluent enough in French
结局指标
主要结局
Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of administration protocol
时间窗: Up to 3 months after inclusion
route, posology, duration, administration sequence, premedication
Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication
时间窗: Up to 3 months after inclusion
neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation
次要结局
- Evaluate in the context of cancer the antalgic efficacy(Up to 3 months after inclusion)
- Evaluate in the context of cancer the tolerance profile(Up to 3 months after inclusion)
- Evaluate in the context of cancer the quality of life including anxiety and depression(Up to 3 months after inclusion)