Evaluating the Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy: A Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Participants' perceived effectiveness
研究概览
简要总结
The study aims to evaluate the feasibility of a repetitive transcranial magnetic simulation (rTMS) protocol developed for managing pain and other related symptoms associated with chemotherapy-induced peripheral neuropathy in cancer patients.
详细描述
A total of 60 cancer patients who are aged 18 years or above and have persistent peripheral neuropathy for at least 3 months after completion of oxaliplatin-, paclitaxel-, or docetaxel-based chemotherapy will be recruited. After randomization, the experimental group (n = 30) will receive high-frequency rTMS, while the control group (n = 30) will receive sham rTMS. The rTMS will be delivered over M1 (hand representation) of dual hemispheres with 10 trains of 10 Hz pulses for 10 seconds, with a total of 1,000 pulses per hemisphere. The rTMS intensity will be set as 80% resting motor threshold and the interval between each train of pulses will be set as 50 seconds. The rTMS will be delivered as daily session for five consecutive days, followed by two fortnightly maintenance sessions during the follow-up period after the completion of five daily sessions. The rTMS will be delivered by designated physical therapists using "figure-of-8" shaped coil connected to an electromagnetic stimulator in the rehabilitation therapy room of the study hospitals in mainland China.
The research outcomes are feasibility (1. recruitment: i.e. the length of time spent on recruiting participants, the mean number of participants been recruited each month, and the proportion of eligible patients who are finally recruited in the study; 2. eligibility: the proportion of screened patients meeting the inclusion criteria; 3. retention and attrition rates: the proportion of recruited participants who complete the study or who drop out from the study with or without any reason; and 4. appropriateness of clinical outcome measures: the proportion of incomplete questionnaires and neurological tests, as well as the characteristics of the missing data.), acceptability (Chinese version of the Patients' Global Impression of Change [PGIC] scale), safety, and trend of improvement in pain, other related symptoms, and quality of life by rTMS in cancer patients with CIPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •have completed oxaliplatin-, paclitaxel-, or docetaxel-based chemotherapy for at least 3 months;
- •complain of persistent symptoms associated with CIPN such as numbness, tingling, burning, or pain with scores ≥ 4 on a numerical rating scale for average daily intensity (0-10, with 10 being the worst) and/or determined as grade 2 or higher CIPN by oncologist according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 (2017);
- •with decreased vibration and/or pinprick sensations according to neurological test (provided by the doctoral researcher when patients was referred by their oncologists);
- •have a Karnofsky Performance Score ≥ 70;
- •can travel to the research hospitals for receiving the study intervention.
排除标准
- •having brain tumor or brain metastasis;
- •having pregnancy;
- •having implanted medical devices;
- •having history of epilepsy, brain lesion, head trauma, neurosurgical procedures, or intracranial hypertension;
- •having a diagnosis of psychiatric disorder (e.g. bipolar, ongoing major depression, or schizophrenia) and/or treating with antipsychotic drugs;
- •having preexisting peripheral neuropathy before initiation of chemotherapy; g) withdrawing from alcohol or sedative medications;
- •having a life expectancy less than six months;
- •treating with naloxone, which can block analgesic effect of rTMS over M1;
- •previously treated with rTMS. Patients receiving any other treatment for CIPN may not be excluded, but they will be required not to change the type and dosage of the current treatments. Furthermore, such information will be collected as baseline clinical data and will be treated as confounding factors during data analysis.
结局指标
主要结局
Participants' perceived effectiveness
时间窗: Baseline up to 5 weeks
In this study, affective attitude and perceived effectiveness will be measured by using the Chinese version of the Patient Global Impression of Change (PGIC) scale, a single-item 7-point numerical rating scale from 1 to 7 demonstrating participants' subjective perception of improvement and satisfaction after receiving the intervention (Hurst \& Bolton, 2004). The PGIC scale has been recommended by the rTMS research guideline for pain (Klein et al., 2015).
Recruitment rate
时间窗: Through study completion, an average of 1 year.
The proportion of eligible patients who are finally recruited in the study.
Eligibility rate
时间窗: Through study completion, an average of 1 year.
The proportion of screened patients meeting the inclusion criteria.
Retention/attrition rate
时间窗: Through study completion, an average of 1 year.
The proportion of recruited participants who complete the study or who drop out from the study with or without any reason.
Appropriateness of clinical outcome measures
时间窗: Through study completion, an average of 1 year.
The proportion of incomplete questionnaires and neurological tests.
Recruitment time
时间窗: Through study completion, an average of 1 year.
The mean number of participants been recruited each month.
次要结局
- Neuropathic symptoms and signs(Baseline up to 5 weeks)
- Health-related quality of life(Baseline up to 5 weeks)
- Adverse Effects(Baseline up to 5 weeks)
- Pain perception(Baseline up to 5 weeks)
- Miscellaneous symptoms associated with CIPN(Baseline up to 5 weeks)