Trial Information

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

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.