Single-Institution Trial Investigating the Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in Taxane Induced Peripheral Neuropathy (CIPN) in Patients With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
研究概览
简要总结
This phase II trial examines transcutaneous electrical nerve stimulation (TENS) in patients with stage I-III breast cancer with chemotherapy induced peripheral neuropathy. TENS is a procedure in which mild electric currents are applied to some areas of the skin to potentially improve neuropathy. This trial may help determine if TENS is feasible and effective for the treatment of peripheral neuropathy symptoms while on chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of daily transcutaneous electrical nerve stimulation (TENS) by measuring participant adherence to TENS for two weeks.
SECONDARY OBJECTIVES:
I. To evaluate the change in patient reported outcome (PRO) measures of symptoms (e.g. pain, tingling, numbness) and functional impairment.
II. To evaluate the change in objective measures of neuropathy over the study period through bedside monofilament testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy regimen that contains paclitaxel or docetaxel.
- •At least Common Terminology Criteria for Adverse Events (CTCAE) grade 1 CIPN in hands or feet attributed to taxane chemotherapy.
- •Actively undergoing paclitaxel or docetaxel with plans to continue during the two-week TENS treatment.
- •Age >= 18 years
- •For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to starting TENS
- •Given the potential concern that TENS could induce uterine contractions or interfere with fetal cardiac conduction, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- •Female of childbearing potential (FCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of TENS treatment. Should a woman become pregnant or suspect she is pregnant during the two weeks of TENS, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- •Willingness and ability of the subject to comply with scheduled visits, TENS administration plan, other study procedures, and study restrictions.
- •Evidence of a personally signed informed consent indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
- •Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
- •Women of child bearing potential (FCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
排除标准
- •Skin wounds, skin breakdown or edema at the site of TENS electrode pad placement
- •History of epilepsy
- •Implanted electronic device including a cardiac pacemaker, defibrillator, pain pump etc.
- •Pre-existing neuropathy
- •Prior exposure to neurotoxic chemotherapy
- •Previous use of TENS for CIPN
- •Prisoners or an adult who is unable to consent
- •Pregnancy
研究组 & 干预措施
Supportive Care (TENS)
Patients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Transcutaneous Electrical Nerve Stimulation (Other)
结局指标
主要结局
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
时间窗: Up to 2 weeks
Adherence for each trial participant will be calculated by summing the number of one-hour TENS sessions completed and dividing by 14 total treatments. Adherence for the cohort will be summarized descriptively using descriptive statistics.
次要结局
- Change in Patient Reported Outcomes Measurement Information System 29 score(At baseline and 2 and 6 weeks)
- Change in Monofilament Testing(At baseline and 2 and 6 weeks)
研究者
Manali Bhave
Principal Investigator
Emory University