Blood and Lymph Conditions

All Conditions

Lymphedema

Lymphatic Diseases

Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Bioelectric Impedance Analysis

Exercise

Photoplethysmography

Questionnaire Administration

The Ohio State Comprehensive Cancer Center

Shannon Hainline

Carlo M. Contreras, MD

Carlo M Contreras, MD

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.

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.

Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema

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).

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.

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.

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.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Neoplasms

Carcinoma

Head and Neck Neoplasms

Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.

Computed Tomography

Positron Emission Tomography

Quality-of-Life Assessment

Radiation Therapy

Clifton D Fuller

Bioelectrical impedance analysis measures body mass (the amount of muscle and fat in the body) and the level of hydration to help researchers identify patients who are losing muscle mass during radiation therapy. This information may help researchers make decisions about nutritional supplementation and the placement of feeding tubes in patients receiving radiation therapy.

PRIMARY OBJECTIVES:

I. To validate body composition estimates derived from the seca (SECA) medical body composition analyzer (mBCA) bioelectrical impedance analysis (BIA) scale by comparing with computed tomography (CT) measured lean and fat body mass.

SECONDARY OBJECTIVES:

I. Evaluate sensitivity of mBCA to detect changes in body composition during treatment.

II. Identify whether BIA-estimated loss of lean body mass (LBM) during treatment predicts development of sarcopenia.

III. Determine whether BIA-derived estimates of body water correlate with requirements for intravenous (IV) hydration and unplanned hospital admissions.

IV. Explore associations between body composition and symptom burden during treatment.

OUTLINE:

Patients undergo bioelectrical impedance analysis with seca mBCA and CT or positron emission tomography (PET) at baseline, weekly for 6-7 weeks during standard of care radiation therapy (RT), and at 10-12 weeks after completion of RT.

After completion of study, patients are followed up every 3 months for 2 years.

Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy

Validation of Eight-Electrode Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition in a Head and Neck Cancer Population Undergoing Radiation Therapy

a. Bioelectrical impedance analysis (BIA) estimates of total body water (kg)

b. incidence of unplanned hospitalizations (#)

Exploratory analyses will evaluate whether decreases in lean mass measured during treatment correlates to the presence of sarcopenia on follow up.

Exploratory analyses will evaluate whether decreases in lean mass measured during treatment correlates to the incidence of therapeutic feeding tube use.

a. MD Anderson Symptom Inventory-Head and Neck (MDASI-HN)

b. Brief patient interviews to assess performance status (ECOG PS) Scores 0-5

Validation of BIA measures of body composition made by comparison with CT-based estimates of body composition.

Linear regression analysis used to determine the relative agreement between lean body mass and fat body mass predicted from impedance measurement and CT imaging.

Root mean square error analysis will be utilized to quantify the average error from BIA-derived body composition calculations.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.

Biospecimen Collection

Cardiopulmonary Exercise Testing

Echocardiography

Physical Performance Testing

Pulmonary Function Test

Ultrasound

Saro H. Armenian

Saro H Armenian

This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.

PRIMARY OBJECTIVES:

I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.

II. Define the determinants of VO2peak impairment in HCT survivors.

OUTLINE:

Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.

Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)

We will measure initial VO2peak in patients prior to HCT and its post-HCT trajectory over time; compare VO2peak in HCT survivors at baseline (pre-HCT), 6m, 1Y, and 2Y post-HCT to established age- and sex-normative data; and define the association between VO2peak and self-reported health-related quality of life (HRQOL) at baseline/over time.

We will use Generalized Estimating Equation(GEE) and generalized linear models to examine the correlation between VO2peak and measures of:

1. cardiac (left ventricular function/ contractility \[systolic, diastolic, cardiac output, strain\], ventricular-arterial (VA) coupling, arterial elastance);
2. pulmonary (obstructive, restrictive lung disease, diffusion capacity);
3. musculoskeletal (body composition \[% lean muscle mass\], muscle quality, two minute step in place test, 30 second sit to stand test, timed up and go); and
4. hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study	NCT06305884	Hematopoietic a... Lymphedema Malignant Solid...	Bioelectric Imp... Exercise Photoplethysmog... Questionnaire A...	18 Years - 90 Years	Ohio State University Comprehensive Cancer Center
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study	NCT06305884	Hematopoietic a... Lymphedema Malignant Solid...	Bioelectric Imp... Exercise Photoplethysmog... Questionnaire A...	18 Years - 90 Years	Ohio State University Comprehensive Cancer Center
Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy	NCT02615275	Head and Neck C...	Bioelectric Imp... Computed Tomogr... Positron Emissi... Quality-of-Life... Questionnaire A... Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study	NCT04537871	Acute Lymphobla... Acute Myeloid L... Hematopoietic a... Hodgkin Lymphom... Myelodysplastic... Non-Hodgkin Lym... Plasma Cell Mye...	Bioelectric Imp... Biospecimen Col... Cardiopulmonary... Echocardiograph... Physical Perfor... Pulmonary Funct... Questionnaire A... Ultrasound	18 Years -	City of Hope Medical Center
Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy	NCT02615275	Head and Neck C...	Bioelectric Imp... Computed Tomogr... Positron Emissi... Quality-of-Life... Questionnaire A... Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy	NCT02615275	Head and Neck C...	Bioelectric Imp... Computed Tomogr... Positron Emissi... Quality-of-Life... Questionnaire A... Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study	NCT04537871	Acute Lymphobla... Acute Myeloid L... Hematopoietic a... Hodgkin Lymphom... Myelodysplastic... Non-Hodgkin Lym... Plasma Cell Mye...	Bioelectric Imp... Biospecimen Col... Cardiopulmonary... Echocardiograph... Physical Perfor... Pulmonary Funct... Questionnaire A... Ultrasound	18 Years -	City of Hope Medical Center

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