Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dimenhydrinate

Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed before treatment and after completion of treatment. Moving On assessments will be performed at first and last study visits.

Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed at first and last study visits.

SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. Participants will be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes. A total of 5 SOZO measurements will be recorded over 12 weeks.

SOZO Device

DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.

DEXA Scan

Larry Gluck, MD

The purpose of this study is to assess how bone density and body composition changes after a cancer patient completes treatment and through 12-weeks post-treatment. Patients who enroll in the 12-week exercise program, Moving On, and those that do not elect to participate in the Moving On program will both be tracked, with assessments including SOZO measurements, DEXA scan (bone density and whole body composition), performance status tests, food log, urine color test, and other study assessments.

This is an observational, prospective, parallel-arm device use study. 50 subjects will be enrolled in the study. The study will look at the changes in the participants body composition post cancer treatment using the SOZO device. The SOZO device is intended to estimate the following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition (fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI), Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during 12 weeks where SOZO measurements will be taken as well as other study measurements.

Body Composition Post Cancer Treatment

Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

Change from baseline in body composition measures (intracellular fluid, extracellular fluid, fat mass, fat free mass, skeletal muscle mass, phase angle, and hydration index)

Evaluate patient general health using physical performance tests

Assess correlation of SOZO measurements with 3-day food recall.

Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results.

Assess correlation of SOZO measurements with standard of care measurements.

Change from baseline in Brief Fatigue Inventory score

Change from baseline in Suscro Distress Inventory score

Assess correlation of SOZO measurements with urine color test.

ImpediMed Limited

Prisma Health-Upstate

Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.

SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes.

The purpose of this study is to assess how bone density and body composition changes over a cancer patient's treatment via SOZO measurements, DEXA scan (bone density and whole body composition), performance status tests, food log, urine color test, and other study assessments. These assessments will begin after cancer diagnosis but prior to intervention, and continue during treatment and at post-treatment visits.

This is an observational, prospective device use study. 50 subjects will be enrolled in the study. The study will look at the changes in the participants body composition as they go through cancer treatment using the SOZO device. The SOZO device is intended to estimate the following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition (fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI), Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during the course of their cancer treatment where SOZO measurements will be taken as well as other study measurements.

Body Composition During Cancer Treatment

Assessment of Body Composition During Cancer Treatment Using the SOZO Device

Assess change in body composition from baseline to final visit

Assess correlation of SOZO measurements with 24-hour food recall.

Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results

Assess correlation of SOZO measurements with standard of care measurements

Change from baseline in 6 minute walk test distance

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Breast Neoplasms

Edema

Lymphedema

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Postoperative Complications

Screening procedures confirm participation in the research study.

* Participants limb volume is measured prior to treatment start date.
* Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
* Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication

The perometer uses light sensors to calculate the length and volume of your arms

Perometer

The machine measures the amount of fluid on the arm(s)

SOZO device

Alphonse G. Taghian, MD

This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.

A Perometer and Sozo devise will be used to measure volume changes

This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished.

A Perometer and Sozo device will be used to measure volume changes

All participants will be accrued at Massachusetts General Hospital for a target accrual of 142 participants

Screening For BCRL In Targeted Therapy For Breast Cancer

Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery

The cumulative incidence curves of the study and control groups and comparing hazard rates after accounting for important covariates in a multivariate Cox proportional-hazards model

Comparison of the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTorr).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Body Composition Post Cancer Treatment	NCT03690401	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Body Composition During Cancer Treatment	NCT03784911	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Body Composition Post Cancer Treatment	NCT03690401	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate
Screening For BCRL In Targeted Therapy For Breast Cancer	NCT05142800	Lymphedema Lymphedema Arm Lymphedema of U... Lymphedema of U... Lymphedema of t... Edema Edema Arm Breast Cancer L... Breast Cancer M... Breast Cancer S... Breast Cancer	Perometer SOZO device	18 Years - 80 Years	Massachusetts General Hospital
Body Composition Post Cancer Treatment	NCT03690401	Cancer	SOZO Device DEXA Scan	18 Years -	Prisma Health-Upstate

Spots Global Cancer Trial Database for sozo device

Every month we try and update this database with for sozo device cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sozo device

Every month we try and update this database with for sozo device cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sozo device cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.