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Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device

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ClinicalTrials.gov Identifier: NCT03252145
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Betty Smoot, University of California, San Francisco

Brief Summary:
This study will be a 4 to 6 week randomized, controlled, assessor blinded, trial comparing a negative pressure massage device (intervention group), to the standard manual lymph drainage massage (control group), in breast cancer patients with chronic upper extremity lymphedema.

Condition or disease Intervention/treatment Phase
Lymphedema, Secondary Lymphedema of Upper Limb Device: PhysioTouch Other: Manual Lymph Drainage (MLD) Not Applicable

Detailed Description:

Lymphedema (LE) is a protein-rich interstitial swelling caused by reduced lymph transport secondary to lymphatic system damage from cancer treatments. 1 in 5 women will develop LE following breast cancer treatment. These women have greater restrictions in activity and poorer quality of life (QOL) and are more prone to cellulitis than women without LE. LE is incurable and progressive. Persistent lymph stasis creates a condition of chronic inflammation that contributes to fibrosis and fatty deposition in the subcutis of the affected limb. The fibro-adipose changes associated with chronic LE make it less responsive to treatments that primarily target limb volume. Treatments are needed that can improve these skin and subcutaneous tissues changes, as well as reduce limb volume.

This 4 to 6 week randomized controlled pilot feasibility study will enroll 80 women with chronic arm LE, and will evaluate a novel negative pressure massage device that mobilizes skin and subcutaneous tissue. This negative pressure treatment provides vertical (lifting) and horizontal stretching of the skin and underlying fascial structures, which increases the subcutaneous space for lymphatic circulation, improves lymph flow, and has the potential to decrease fibrosis. This treatment will be compared to the standard of care massage: manual lymphatic drainage. Women will be randomly assigned to either the negative pressure massage device (intervention group), to the standard manual lymph drainage massage (control group)

Objectives: To evaluate recruitment and retention rates; to determine rates of adverse events; and to determine effect sizes for limb volume, tissue induration; and patient reported outcomes of arm function, QOL, and body image in response to treatment

An additional exploratory aim of the study is to evaluate for changes in circulating biomarkers of inflammation and fibrosis following treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device: A Feasibility Study
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Negative Pressure
PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb
Device: PhysioTouch
The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.

Active Comparator: Manual Lymph Drainage
Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb
Other: Manual Lymph Drainage (MLD)
MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.




Primary Outcome Measures :
  1. Recruitment rates [ Time Frame: 4 weeks ]
    Recruitment rates for both arms of this study will be evaluated. The numbers of women screened and enrolled will be recorded. Reasons for declining participation in those eligible but not enrolled will be ascertained.

  2. Retention rates [ Time Frame: 4 weeks ]
    Retention rates for both arms of this study will be evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.


Secondary Outcome Measures :
  1. Limb volume [ Time Frame: At baseline ]
    Arm circumferential measurements of both limbs and hands. will be taken twice, using a spring-loaded tape measure. The hand will be measured in two locations. Upper extremity measurements will be taken at 10 cm intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences will be measured using the procedures outlined by Cornish et al. Limb volume will be calculated using the formula for volume of a truncated cone.

  2. Limb volume [ Time Frame: At 4 weeks ]
    Arm circumferential measurements of both limbs and hands. will be taken twice, using a spring-loaded tape measure. The hand will be measured in two locations. Upper extremity measurements will be taken at 10 cm intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences will be measured using the procedures outlined by Cornish et al. Limb volume will be calculated using the formula for volume of a truncated cone.

  3. Bioimpedance Spectroscopy (BIS) resistance ratios as a measure of extracellular fluid volume. [ Time Frame: At baseline ]
    BIS measurements of both arms will be done using established procedures. BIS measurements will be taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate UE impedance. The BIS resistance ratio will be calculated as the ratio of resistance in the unaffected arm to the resistance in the affected arm.

  4. Bioimpedance Spectroscopy (BIS) resistance ratios as a measure of extracellular fluid volume. [ Time Frame: At 4 weeks ]
    BIS measurements of both arms will be done using established procedures. BIS measurements will be taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate UE impedance. The BIS resistance ratio will be calculated as the ratio of resistance in the unaffected arm to the resistance in the affected arm.

  5. Skin induration [ Time Frame: At baseline ]
    The SkinFibroMeter (Delfin Technologies, Finland) will be used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings will be taken at each location and a mean score will be calculated.The induration value in Newtons (N) is recorded.

  6. Skin induration [ Time Frame: At 4 weeks ]
    The SkinFibroMeter (Delfin Technologies, Finland) will be used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings will be taken at each location and a mean score will be calculated.The induration value in Newtons (N) is recorded.

  7. Shoulder range of motion [ Time Frame: At baseline ]
    Active shoulder flexion and abduction range of motion (ROM) will be assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM will be assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.

  8. Shoulder Range of Motion [ Time Frame: At 4 weeks ]
    Active shoulder flexion and abduction range of motion (ROM) will be assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM will be assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.

  9. Grip Strength [ Time Frame: At baseline ]
    Grip strength will be assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient will be instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in pounds) calculated.

  10. Grip Strength [ Time Frame: At 4 weeks ]
    Grip strength will be assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient will be instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in pounds) calculated.

  11. Functional status - The Karnofsky Performance Status scale [ Time Frame: At baseline ]
    The Karnofsky Performance Status (KPS) scale is widely used to evaluate functional status in patients with cancer and has well established validity and reliability.38,39 Participants will rate their functional status using the KPS scale that ranges from 30 (I feel severely disabled and need to be hospitalized) to 100 (I feel normal; I have no complaints or symptoms).

  12. Functional status - The Karnofsky Performance Status scale [ Time Frame: At 4 weeks ]
    The Karnofsky Performance Status (KPS) scale is widely used to evaluate functional status in patients with cancer and has well established validity and reliability.38,39 Participants will rate their functional status using the KPS scale that ranges from 30 (I feel severely disabled and need to be hospitalized) to 100 (I feel normal; I have no complaints or symptoms).

  13. Medical comorbidities - The Self-Administered Comorbidity Questionnaire [ Time Frame: At baseline ]
    The Self-Administered Comorbidity Questionnaire (SCQ) consists of 13 common medical conditions that were simplified into language that could be understood without any prior medical knowledge. Patients are asked to indicate if they had the condition using a "yes/no" format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum score totals 45 points if the open-ended items are used and 39 points if only the closed-ended items are used.

  14. Lymphedema associated symptoms - Norman Questionnaire [ Time Frame: At baseline ]
    The Norman Questionnaire (NQ) was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related LE. Using the NQ, a woman reports subjective differences in the sizes of the hands, lower arms, and/or upper arms between sides. For each site difference, the reported score can range from 1 (very slight) to 3 (very noticeable). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). The psychometric properties of the NQ are well established. Additional NQ questions relate to skin condition, and feelings of tiredness, thickness, or heaviness (but are not included in the NQ score).

  15. Lymphedema associated symptoms - Norman Questionnaire [ Time Frame: At 4 weeks ]
    The Norman Questionnaire (NQ) was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related LE. Using the NQ, a woman reports subjective differences in the sizes of the hands, lower arms, and/or upper arms between sides. For each site difference, the reported score can range from 1 (very slight) to 3 (very noticeable). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). The psychometric properties of the NQ are well established. Additional NQ questions relate to skin condition, and feelings of tiredness, thickness, or heaviness (but are not included in the NQ score).

  16. Lymphedema associated symptoms - Norman Questionnaire [ Time Frame: At 4 months ]
    The Norman Questionnaire (NQ) was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related LE. Using the NQ, a woman reports subjective differences in the sizes of the hands, lower arms, and/or upper arms between sides. For each site difference, the reported score can range from 1 (very slight) to 3 (very noticeable). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). The psychometric properties of the NQ are well established. Additional NQ questions relate to skin condition, and feelings of tiredness, thickness, or heaviness (but are not included in the NQ score).

  17. Upper extremity function - The Disability of Arm, Shoulder, Hand Questionnaire (DASH) [ Time Frame: At baseline ]
    The Disability of Arm, Shoulder, Hand Questionnaire (DASH) is a valid and reliable 30-item self-report questionnaire that measures upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb and is frequently used in LE research. DASH scores range from 0 to 100. Higher scores indicate greater limitation.

  18. Upper extremity function - The Disability of Arm, Shoulder, Hand Questionnaire (DASH) [ Time Frame: At 4 weeks ]
    The Disability of Arm, Shoulder, Hand Questionnaire (DASH) is a valid and reliable 30-item self-report questionnaire that measures upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb and is frequently used in LE research. DASH scores range from 0 to 100. Higher scores indicate greater limitation.

  19. The PROMIS Physical Function for the Upper Extremity [ Time Frame: At baseline ]
    The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 "not at all" to 5 "very much." Total scores range from 0 to 100.

  20. The PROMIS Physical Function for the Upper Extremity [ Time Frame: At 4 weeks ]
    The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 "not at all" to 5 "very much." Total scores range from 0 to 100.

  21. Physical function - PROMIS 29 Version 2 - Participant Version [ Time Frame: At baseline ]
    The PROMIS 29 consists of 29 questions that address physical function, anxiety, depression, fatigue, sleep, social roles, and pain. Higher scores indicate higher levels of function.

  22. Physical function - PROMIS 29 Version 2 - Participant Version [ Time Frame: At 4 weeks ]
    The PROMIS 29 consists of 29 questions that address physical function, anxiety, depression, fatigue, sleep, social roles, and pain. Higher scores indicate higher levels of function.

  23. Quality of life - Functional Assessment of Cancer Therapy-Breast [ Time Frame: At baseline ]
    The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a valid and reliable self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B includes 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer.

  24. Quality of life - Functional Assessment of Cancer Therapy-Breast [ Time Frame: At 4 weeks ]
    The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a valid and reliable self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B includes 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer.

  25. Body Image [ Time Frame: At baseline ]
    The Body Image Scale (Hopwood) is a 10-item questionnaire that gathers information about body image specifically in people with cancer. Items include 4 response options, from 1 "not at all" to 4 "very much." The scale showed high reliability, good clinical validity, and sensitivity to change.

  26. Body Image [ Time Frame: At 4 weeks ]
    The Body Image Scale (Hopwood) is a 10-item questionnaire that gathers information about body image specifically in people with cancer. Items include 4 response options, from 1 "not at all" to 4 "very much." The scale showed high reliability, good clinical validity, and sensitivity to change.

  27. Treatment Satisfaction [ Time Frame: At 4 weeks ]
    Satisfaction with treatment will be evaluated at the 4-week assessment using the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TSG- Version 4).

  28. Biomarkers [ Time Frame: At 4 weeks ]
    Changes in circulating biomarkers of inflammation and fibrosis (IL-4, IL-6, IL-10, IL-13 aND TGF-beta 1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

To be included women must be:

Be over 18 years of age;

Have had cancer treatment that included a surgical procedure, radiation therapy (RT), and/or chemotherapy (CTX);

Have completed active cancer treatment at least 1 year prior to study enrollment;

Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment;

Have arm lymphedema on one side only;

Have confirmed LE based on bioimpedance measurements with an LDex score of >7.1 (note - this is very mild lymphedema);

Have stable arm LE. LE will be considered "stable" if during the 3 months prior to study enrollment there was no arm infection requiring antibiotics, no change in ability to perform activities of daily living related to LE, and no subjective report of significant persistent changes in limb volume;

Be mentally and physically able to participate in the study;

Be able to attend the sessions at the UCSF Parnassus campus;

Read and understand English;

Be able to understand a written informed consent document and the willingness to sign it

EXCLUSION CRITERIA

Women cannot have:

Bilateral upper extremity LE;

Current infection or lymphangitis involving the affected arm;

Current recurrence of their BC (local or distant)

Pre-existing LE prior to their BC diagnosis;

A condition that precludes measurement of LE using BIS, including pregnancy;

Current venous thrombosis in either upper extremity or be on current anticoagulant therapy;

Extremity edema due to heart failure


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252145


Contacts
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Contact: Betty Smoot, DPTSc, MAS 707 494 8262 betty.smoot@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Betty Smoot, DPTSc, MAS    707-494-8262    betty.smoot@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Betty Smoot, DPTSc, MAS University of California, San Francisco

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Responsible Party: Betty Smoot, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03252145     History of Changes
Other Study ID Numbers: P0518095
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes