Hematopoietic and Lymphoid System Neoplasm, Lymphedema, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
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. III. Use a combination of photoplethysmography and bioimpedance to identify likely cut points for lymphedema in participants with lymphedema. OUTLINE: Participants undergo BI and wear watch-like sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
Interventions
PROCEDUREBioelectric Impedance Analysis
Undergo BI
OTHERExercise
Pedal an exercise bike
PROCEDUREPhotoplethysmography
Undergo PPG
BEHAVIORALQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unique signature describing photoplethysmography and bioimpedance at rest and during activity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes | Up to 2 hours | Assess by the Lymph-Q questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables. |
| Tolerability of sensors | Up to 2 hours | Assess by the Tolerability questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables. |
| Likely classification for lymphedema | Up to 2 hours | Will examine receiver operator characteristics using data from groups 3 and 4. Sensitivity, specificity, and area under that curve will be calculated, however these will be considered preliminary. |
Countries
United States
Outcome results
None listed