Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Unique signature describing photoplethysmography and bioimpedance at rest and during activity
研究概览
简要总结
This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.
详细描述
PRIMARY OBJECTIVE:
I. Describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes participants with lymphedema in comparison to participants without lymphedema at rest.
SECONDARY OBJECTIVES:
I. In participants with lymphedema, describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes the affected arm in comparison to the unaffected arm.
II. Tolerability of the transcutaneous sensors during the participant data collection session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COHORT A: Healthy participants
- •COHORT B: Participants with pre-existing lymphedema
- •COHORT B: A history of cancer therapy with surgery or radiation involving the axillary basin
- •COHORT B: Unilateral upper extremity swelling that requires compression or pneumatic therapy or a >= 2-centimeter difference in contralateral arm circumference
排除标准
- •Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included
研究组 & 干预措施
Diagnostic (BI, PPG)
Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
干预措施: Exercise (Other)
Diagnostic (BI, PPG)
Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
干预措施: Photoplethysmography (Procedure)
Diagnostic (BI, PPG)
Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
干预措施: Questionnaire Administration (Behavioral)
Diagnostic (BI, PPG)
Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
干预措施: Bioelectric Impedance Analysis (Procedure)
结局指标
主要结局
Unique signature describing photoplethysmography and bioimpedance at rest and during activity
时间窗: Up to 2 hours
Will assess in the following groups: (1) Healthy dominant arm, (2) healthy recessive arm, (3) lymphedema normal arm and (4) lymphedema affected arm. A single continuous value will be developed from the amplitude over time for each participant, both at rest and during activity. These measurements will be summarized using descriptive statistics (means, standard deviations or medians and interquartile ranges).
次要结局
- Likely classification for lymphedema(Up to 2 hours)
- Tolerability of sensors(Up to 2 hours)
- Patient reported outcomes(Up to 2 hours)
研究者
Carlo Contreras
Principal Investigator
Ohio State University Comprehensive Cancer Center