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

All Drugs and Chemicals

Methylene Blue

ARM +ve LN PRESERVED , ALND COMPLETED LATER ON

subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels

AXILLARY REVERSE MAPPING

hazem nour, MD

study patients; axillary node negative breast cancer female, 74 patients randomly allocated in two groups each 37 patients , group I , where axillary reverse mapping(ARM) +ve nodes were preserved and axillary lymph node dissection completed.and group II where axillary reverse mapping +ve nodes were taken with axillary lymph node dissection(ALND) primary outcome is histopathological examination of a ARM +ve lymph nodes and volume measurements of the ipsilateral arm for development of lymphedema at 6 ,12 , and 24 months

This study is comparative clinical trial carried out in the period between February 2015 and August 2019 on 74 female patients with early breast cancer. All patients were informed and signed a written consent. The study was approved from institutional review board (IRB) and ethical committee of our university.

Patient selection Patients included in the study are female patients above 18 years old, known breast cancer with clinically negative nodal metastasis who were admitted for completion ALND, after positive sentinel lymph node biopsy (SLNB).

Patients excluded from the study are those who had received chemotherapy for breast cancer, recurrent cases after conservative breast surgery, bilateral disease and pregnant cases.

Patients were randomly divided into two equal groups each 37 patients, group A; (ARM preserving ALND), where arm lymphatics and lymph nodes were identified and preserved, subsequently ALND was completed, group B; where arm lymphatics and lymph nodes were identified, marked and removed with ALND.

Technical procedures:

Axillary reverse mapping (ARM) procedure; one to two ml of methylene blue dye was subcutaneously injected in the upper medial arm in the groove between biceps muscle and triceps muscle then subsequently the area of injection was massaged for 5 minutes. During axillary dissection the (ARM) positive lymphatics and lymph nodes were identified and carefully dissected as the lymphatic vessels are very delicate, in group A the (ARM) positive lymphatics and lymph nodes were preserved and axillary clearance was completed, in group B (ARM) positive lymphatics and lymph nodes were identified, dissected, marked and taken out with ALND. The procedures were carried out with oncological surgeons familial with ALND. The limits of axillary dissection was axillary vein from above, lateral border subscapularis muscle laterally and medial border of pectoralis minor medially, long thoracic and lateral thoracic nerves were preserved intercostobrachial nerve wasn't preserved in all cases.

Data collection

* Preoperative data including demographic criteria, histopathological findings of breast biopsy and SLNB, preoperative measurement of arm volume by water displacement, circumferential measurement of the arm at the metacarpopharyngeal level, wrist level, 10 cm and 15 cm distal and proximal to the lateral epicondyle respectively.
* State of ARM positive or negative
* Follow up was carried out on outpatient clinic basis, monthly in the first 6 months then every 3 months for 2 years for data collection and later dates for regular follow up. Data was recorded including ARM histopathology (considered as the primary outcome), development of lymphedema defined as increase in arm volume by 10 % of the original size, tingling, numbness, paraesthesia and restricted shoulder movement were considered secondary outcome. Shoulder movement restriction was calculated by decrease of abduction by 10 degrees in comparison to the contralateral arm, development of local axillary recurrences, arm volume was measured at 6,12 and 24 months by water displacement method.

The collected data was properly analyzed using the proper statistical methods in SPSS 21 package.

2 groups of patients each 37 patient with early breast cancer one underwent ARM +ve LN biopsy with ALND, the other underwent ARM+ve LN preservation with completion of ALND

Axillary Reverse Mapping Using Methylene Blue Subcutaneous Injection Can Identify Arm Lymph Nodes and Vessels, Measuring Arm Size for Lymphedema, Histopathological Examination of Arm Lymph Nodes Included With Axillary Lymph Node Dissection

Evaluation of Axillary Reverse Mapping (ARM) in Clinically Axillary Node Negative Breast Cancer Patients

Zagazig University

Assistant professor

Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed

Hypofractionated radiotherapy scheme

Maria Cristina Leonardi, MD

Maria Cristina Leonardi

In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections.

In recent years, breast oncologic surgery has aimed to omit axillary dissection in cases where no more than two sentinel lymph nodes are positive, particularly when complementary radiotherapy to the whole breast is planned.

Radiation therapy to the axillary lymph nodes ensures excellent locoregional control in patients with primary tumor no more than 5 centimeter and 1-2 macrometastatic sentinel lymph nodes, and appears to carry fewer side effects than axillary dissection.

Arm lymphedema is indeed one of the most well-known long-term complications of breast cancer treatment, impacting the quality of life for patients undergoing lymphadenectomy. In this scenario, the study proposes a treatment of hypofractionated intensity-modulated radiotherapy (IMRT) to the breast and axillary lymph nodes with the aim of further containing the risk of developing ipsilateral arm lymphedema. IMRT improves the dosimetric profile of surrounding organs at risk in the treated area, with better dose conformity to the target volume compared to tangential fields used in conventional 3D conformal techniques (as employed in most trials described so far).

Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

AXILL-ART: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes Without Axillary Dissection in Breast Cancer Conservative Surgery: Observational Study

Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale

Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward

Number of patients with an oncological event (local, regional and distant recurrence free survival)

Number of patient alive after 5 years of follow up

Numeric Rating Scale (NRS) (NRS-11) is an 11-point scale for patient self-reporting of pain. It is used for rating symptoms like pain, itching and burning

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
Axillary Reverse Mapping Using Methylene Blue Subcutaneous Injection Can Identify Arm Lymph Nodes and Vessels, Measuring Arm Size for Lymphedema, Histopathological Examination of Arm Lymph Nodes Included With Axillary Lymph Node Dissection	NCT04137744	Arm Lymphedema Lymphatic Sprea... Early Breast Ca...	AXILLARY REVERS...	18 Years -	Zagazig University
Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes	NCT06321653	Arm Lymphedema Breast Cancer Radiotherapy Si...	Hypofractionate...	18 Years -	European Institute of Oncology
Axillary Reverse Mapping Using Methylene Blue Subcutaneous Injection Can Identify Arm Lymph Nodes and Vessels, Measuring Arm Size for Lymphedema, Histopathological Examination of Arm Lymph Nodes Included With Axillary Lymph Node Dissection	NCT04137744	Arm Lymphedema Lymphatic Sprea... Early Breast Ca...	AXILLARY REVERS...	18 Years -	Zagazig 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 arm lymphedema