Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Intervention of arm compression only by Flexitouch System

Intervention of arm, trunk and chest compression by Flexitouch System

( 10 to 30 treatments depending on group assignment)

Flexitouch System

Sheila H Ridner, Phd

No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema.

Hypotheses:

Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance \& arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System.

H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System.

H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System.

H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire \[FASQ\] will improve after 10 sessions with the Flexitouch® System.

Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance \& arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only).

H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only).

H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only) .

H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only).

Screening Procedures This study will have a three-phase screening process.

Phase One:

Participants will be screened either in person or via the telephone.

Phase Two:

If the person being interviewed is eligible and interested, study staff will obtain phone consent for a brief interview to obtain basic medical and treatment information and to share this information with the study doctor, who will write prescriptions for treatment based upon these data. After a prescription is obtained, study staff will contact participants by phone and schedule the on-site visit.

Phase Three:

Participants will come to the Vanderbilt University for measurement of arms and truncal assessment. Phase Three Screening informed consent will be obtained prior to any measurements. These measurements will serve as baseline entry into the study for those who meet criteria.

Baseline Interview All Participants: Once written informed consent is obtained, study staff will interview the participants to obtain demographic and treatment (lymphedema and breast cancer) history. Participants will complete symptom and quality of life forms.

Part One Study:

Dosage and Setting:

Participants will receive a total of 10 treatments, one hour per day for 10 days consecutively. Treatment One will be conducted under study staff supervision at VUSN or other Vanderbilt location. Treatments Two through Ten will be self-administered, at home, as this is an FDA approved at-home self-care device.

Study staff will make an at home visit for Treatment Two in order to observe the application and use of the device and to measure the participant's trunk and arms and examine arm and trunk.

Home Treatment One Observation and Measurement:

Physical Assessment/Measurement:

* Study staff will visually examine the affected and unaffected arms and truncal areas (collarbone to navel and small of back).
* Participants will be asked to sit at their dining table with arms extended to the side at shoulder height at shoulder level. A non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder. Each arm will be measured 2 times and the average used.
* Study staff will then measure the trunk twice at five locations.
* During bioimpedance: Study staff will assist the patient onto a bed or sofa and measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. This measurement will take less than five minutes. The leads and electrodes will then be removed.
* Study staff will weigh the participant twice and record the average.
* At the end of the treatment session, study staff will again measure the arms and trunk of the participant. Using the same procedures.

Treatment Observation:

Staff will observe for:

* Participants going to restroom, removing any compression garments, constrictive clothing/undergarments or foot coverings they are wearing, and to removing any jewelry prior to treatment.
* Participants changing into scrub suits.
* Use of treatment record checklist to set dials
* Participants resting in a supine position during treatment.
* Appropriate placement of garments.
* Pressures will be set at manufacturers recommended levels of compression using program UEO1/U1 and standard pressure (not intense pressure) only.
* Active time on the device approximately 60 minutes.
* Completion of treatment record checklist after treatment.
* Staff will correct any errors noted and educate as needed.

Measurement Visits (Between Treatment 5 and 6 (+ or - 1 treatment), and within 72 hrs after Treatment 10, Exit from Study):

Data Collection:

Physical Assessment/Measurement:

* Study staff will visually examine the affected and unaffected arms and truncal areas (collarbone to navel and small of back) and document findings on the Skin Checklist.
* Participants will be asked to sit at their dining table with arms extended to the side at shoulder height at shoulder level. A non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder. Each arm will be measured 2 times and the average used.
* Study staff will then measure the trunk at the five locations. During bioimpedance: Study staff will assist the patient to lay flat on a bed or sofa and staff will measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. This measurement will take less than five minutes. The leads and electrodes will then be removed .
* Study staff will weigh the participant twice and record the average.

Interview:

• Participants will complete the symptom and quality of life forms.

Part Two (Experimental and Control Groups)

Dosage and Setting:

Participants will receive a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One will be provided under study staff supervision . Treatments Two through Thirty will be self-administered, at home, as this is an FDA approved at-home self-care device.

Data Collection Initial On-Site Visit:

Physical Assessment/Measurement:

* Participants will be asked to void (for comfort during procedure), to remove any compression garments, constrictive clothing/undergarments, or foot coverings they are wearing, and to remove any jewelry.
* Participants will be asked to change into scrub suits.
* Participants will have their height (using a portable stadiometer) and weight (using a Pro-fit Electronic Scales) measured twice and the average will be recorded .

Treatment:

* Study staff will review the procedure in the manual for self-administration of the device and ask for participants to demonstrate their ability to apply the device and use the appropriate settings. Participants will view a video about the device.
* Participants will apply the Flexitouch® System garments (actual garment to be placed will be determined by randomization to experimental or control group) over and scrubs in the arm and trunk areas.
* Participants will rest supine on the massage table with their head on a pillow, if necessary, during treatment.
* For subjects randomized to the Experimental Group: Pressures will be set at manufacturers recommended levels of compression using the standard upper extremity program (UEO1/U1) and standard pressure (not intense pressure) only. Active time on the device will be approximately 60 minutes.
* For subjects randomized to the Control Group: pressures will be set at manufacturers recommended levels of compression using program for arm compression only (UE04/U4), chest will not receive compression, and standard (not intense pressure) only. Active treatment time for Group B patients will be approximately 40 minutes.
* Study staff will remain present during the treatment. Should a participant experience discomfort or request to stop the treatment, study staff will immediately turn off the device and remove the garments.
* At the end of the treatment session study staff will measure the arms and trunk.
* Trunk will be measured twice using a non-flexible tape.
* Bioelectrical Impedance: Study staff will assist the patient onto a non-metal massage table covered with clean linen and staff will measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. The leads and electrodes will then be removed and cleaned with an alcohol pad.
* Circumferential: With arms extended to the side and at shoulder level, a non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder.

Measurement Visits (After Treatment 14 (+or- 2 treatments) and within 72 hours after Treatment 30 (Exit from Study) :

Data Collection:

If the participant opts to come to Vanderbilt the measurement procedures for arms and weight will be the same as in the first onsite. If the visit takes place at-home the following procedures a will be used:

Physical Assessment/Measurement:

* Study staff will visually examine the affected and unaffected arms and truncal areas (collarbone to navel and small of back) and document findings on the Skin Checklist (Attachment C form 12).
* Participants will be asked to sit at their dining table with arms extended to the side at shoulder height. A non-flexible tape will be used to measure girth at the metacarpal shaft of the hand and then, starting at the ulnar styloid, in 10 cm intervals to the shoulder. Each arm will be measured 2 times and the average used.
* Study staff will then measure the trunk at the five locations noted on Attachment C form 11. Study staff will assist the patient onto a non-metal massage table covered with clean linen and staff will measure arm volume using bioelectrical.
* During bioimpedance: Study staff will ask the patient to lay flat on a bed or sofa and staff will measure arm volume using bioelectrical impedance. Participants will be placed in a supine position with legs not touching one another. An alcohol pad will be used to prep each wrist next to the joint, the dorsal surface of each hand (1 cm proximal to the middle knuckle), and the dorsal surface of one foot (1 cm proximal to the joint of the second toe). These areas will be allowed to dry and lightly adhesive electrodes will be applied. Measurement of affected and unaffected arms will be conducted as directed by the computer software in each impedance device. This measurement will take less than five minutes. The leads and electrodes will then be removed .
* Participants will be weighed twice and the average recorded.

Interview:

• Participants will complete the symptom and quality of life forms.

Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer

measured by tape and then volume was calculated.

Lymphedema Symptom and Intensity Scale-Arm measures 30 symptoms yes no over the past 7 days . Total yes items added for number of symptoms.

Tactile Systems Technology, Inc.

Vanderbilt University

Associate Professor

Arm Compression Only

Arm, Trunck and Chest Compression

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

sheila h ridner

Arm Volume at End of Study

Baseline

End of Treatment

Compression in arm, trunk and chest compression

Arm, Trunk and Chest Compression

Symptom Improvement

Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.

Overall Study

Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)

Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment

Control group, no intervention. No Flexitouch or manual massage therapy

A standard of care intermittent pneumatic compression device (aka, lymphedema pump)

Flexitouch

Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc).

Class 1 compression garment

Stanley G Rockson

To compare the effectiveness of usual treatments for lymphedema \[massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)\], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.

The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, this study assess if physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer (eg, Flexitouch and manual lymphatic massage) will reduce the incidence of lymphatic stagnation, assessed as incidence of lymphedema, when compared to patients who receive conventional "watch and wait" interventions (observation).

The specific aims of the study are

1. to prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance
2. to evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study
3. to correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume

Recent advances in the medical understanding of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a model of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at 1woman in 4 who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. New insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal investigates this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy.

Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status

To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status

Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups

Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.

Stanford University

Professor of Lymphatic Research and Medicine

Flexitouch Device

Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.

Manual Lymphatic Drainage (MLD)

Observational Control (no Intervention)

This group of patients will receive the device.

Group I

This group of patients will receive prophylactic MLD

Group II

This is the control group; they will receive no treatment

Group III

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Stanley G. Rockson

Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)

Lymphedema management via self-administered manual lymphatic drainage therapy

No Intervention Control

All enrolled patients in the trial who did not withdraw or were lost to follow-up

Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy

Lymphedema management via self-administered manual lymphatic massage therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer	NCT00880022	Arm Lymphedema Truncal Lymphed... Breast Cancer	Flexitouch Syst...	21 Years -	Vanderbilt University
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status	NCT00383500	Lymphedema Breast Cancer	Flexitouch Class 1 compres...	18 Years -	Stanford University
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer	NCT00880022	Arm Lymphedema Truncal Lymphed... Breast Cancer	Flexitouch Syst...	21 Years -	Vanderbilt University

Spots Global Cancer Trial Database for flexitouch

Every month we try and update this database with for flexitouch 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 flexitouch

Every month we try and update this database with for flexitouch 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 flexitouch 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.