CTRI/2024/04/065805尚未招募1/2 期
Effectiveness of Cognitive Rehabilitation on Cognition and Quality of Life in Chemotherapy-Induced Cognitive Impairment- A Randomized Control Trial.
Ravi Nair Physiotherapy College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月12日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Mini Mental State Examination
研究概览
简要总结
The study aims to evaluate the effect of cognitive rehabilitation on cognition and quality of life in chemotherapy-induced cognitive impairment in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed patients with stages I to III cancers planning to receive a definitive number of platinum-based compounds chemotherapy.
- •Patients who are given Taxanes and Platinum-based compounds – Cisplastin, Carboplatin and Oxaliplatin 3) 3) Patients having Grade I or II cognitive impairment according to National Cancer Institute –common toxicity criteria.
- •Planned to receive a minimum of 4 cycles of chemotherapy treatment with either of the chemotherapy agents (Platinum based compound) 5) Both Male and female aged grouped between 14-70 years.
- •Patients who are given drugs according to approval of national cancer board.
排除标准
- •Patients having Pre-existing cognitive impairment.
- •Patient having Traumatic Brain Injury.
- •Patients having a previous history of any psychological condition that could impair cognitive function.
- •Patients who did not perceive any chemotherapy cycle after cancer treatment.
- •Patients with a previous history of cancer and chemotherapeutic drugs.
- •Those who were having any neurological disorders in the brain and spinal cord such as Alzheimer’s disease (AD), Lewy body disease, stroke (CVA), Huntington’s disease, MS, ALS, frontotemporal dementia, and vascular dementia; use of medication known to have a negative impact on cognition (benzodiazepines).
- •Use of antipsychotics and cholinesterase inhibitors (CHEIs); current or recent (past 6 months) alcohol or substance use disorder; any behavioural changes like depression, anxiety, stress, other systemic diseases likely to impair cognition, such as hypothyroidism, deï¬ciency of folic acid or vitamin B12, or viral infection (syphilis, HIV); vision and speech impairment (aphasia).
结局指标
主要结局
1. Mini Mental State Examination
时间窗: Baseline data will be collected and data analysis will be done after 4 weeks
2. Montreal Cognitive Assessment
时间窗: Baseline data will be collected and data analysis will be done after 4 weeks
3. Functional Assessment of Cancer Therapy Cognitive
时间窗: Baseline data will be collected and data analysis will be done after 4 weeks
次要结局
- 1. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30(2. Patient Specific Functional Scale)
研究者
Dr Gayatri Kaple
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research
研究点 (1)
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