Trial Outcomes & Findings for Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device (NCT NCT03252145)

NCT ID: NCT03252145

Last Updated: 2021-01-15

Results Overview

The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: At 4 weeks
• Results posted on: 2021-01-15

Participant Flow

Participants were recruited from a University of California, San Francisco 5-year cross-sectional study (CA187160). In addition, flyers were made available to participants at lymphedema and breast cancer conferences and patient symposia. Community collaborators (breast surgeons, lymphedema specialists, support group leaders) were also sent informational and recruitment materials related to the study.

Of the 130 who expressed interest in the study, only 28 met all inclusion criteria.

Participant milestones

Measure	Manual Lymph Drainage Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Overall Study STARTED	13	15
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Manual Lymph Drainage Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Overall Study Withdrawal by Subject	1	0
Overall Study Complicating Disease	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Total n=28 Participants Total of all reporting groups
Age, Customized 30-39 years old	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 40-49 years old	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 50-59 years old	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 60-69 years old	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 70-79 years old	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized 80-89 years old	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: At 4 weeks

The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Recruitment Rates	32.5 rate of recruitment	37.5 rate of recruitment

PRIMARY outcome

Timeframe: At 4 weeks

Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Percentage of Participants Who Completed All Study Visits	84.6 percentage of participants	86.7 percentage of participants

SECONDARY outcome

Timeframe: At Baseline

Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Limb Volume	383.32 ml Standard Deviation 324.74	622.17 ml Standard Deviation 396.39

SECONDARY outcome

Timeframe: At 4 weeks

Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Limb Volume	352.66 ml Standard Deviation 317.74	512.98 ml Standard Deviation 332.77

SECONDARY outcome

Timeframe: At Baseline

Population: The range of L-DEX ratio scores on our study at baseline were 0.1 - 74.20.

Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms & 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Lymphedema Index (L-DEX®) Ratio Scores	23.09 score on a scale Standard Deviation 20.87	34.16 score on a scale Standard Deviation 24.73

SECONDARY outcome

Timeframe: At 4 weeks

Population: The range of L-DEX ratio scores on our study at 4 weeks were -2.85 - 77.50.

Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms & 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean L-DEX® Scores	26.30 score on a scale Standard Deviation 22.23	30.09 score on a scale Standard Deviation 22.72

SECONDARY outcome

Timeframe: At Baseline

The SkinFibroMeter (Delfin Technologies, Finland) was 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 were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Skin Induration Score	0.077 Newtons Standard Deviation 0.023	0.072 Newtons Standard Deviation 0.021

SECONDARY outcome

Timeframe: At 4 weeks

The SkinFibroMeter (Delfin Technologies, Finland) was 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 were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Skin Induration Score	0.069 Newtons Standard Deviation 0.017	0.065 Newtons Standard Deviation 0.017

SECONDARY outcome

Timeframe: At Baseline

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

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Degrees of Shoulder Range of Motion Affected arm	167.5 degrees Standard Deviation 5.0	157.1 degrees Standard Deviation 34.0
Mean Degrees of Shoulder Range of Motion Unaffected arm	168.5 degrees Standard Deviation 6.9	163.7 degrees Standard Deviation 12.7

SECONDARY outcome

Timeframe: At 4 weeks

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

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Degrees of Shoulder Range of Motion Affected arm	170.5 degrees Standard Deviation 6.0	165.5 degrees Standard Deviation 9.5
Mean Degrees of Shoulder Range of Motion Unaffected arm	169.3 degrees Standard Deviation 7.5	164.6 degrees Standard Deviation 11.6

SECONDARY outcome

Timeframe: At Baseline

Grip strength was 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 was 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 kilogram of force) calculated. A higher score indicates a greater grip strength.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Grip Score Affected Arm	24.0 kilograms of force Standard Deviation 4.7	21.5 kilograms of force Standard Deviation 6.4
Mean Grip Score Unaffected Arm	25.7 kilograms of force Standard Deviation 6.8	24.5 kilograms of force Standard Deviation 4.3

SECONDARY outcome

Timeframe: At 4 weeks

Grip strength was 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 was 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 kilograms of force) calculated. A higher score indicates a greater grip strength.

Outcome measures

Measure	Manual Lymph Drainage n=13 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Grip Score Affected arm	26.4 kilograms of force Standard Deviation 6.6	25.2 kilograms of force Standard Deviation 4.1
Mean Grip Score Unaffected arm	25.5 kilograms of force Standard Deviation 6.1	22.6 kilograms of force Standard Deviation 5.5

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire at baseline

Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=13 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Karnofsky Performance Status (KPS) Score	89.12 score on a scale Standard Deviation 13.79	88.18 score on a scale Standard Deviation 8.74

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire at 4 weeks

Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=13 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Karnofsky Performance Status (KPS) Score	91.8 score on a scale Standard Deviation 4.04	90.91 score on a scale Standard Deviation 9.44

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire at baseline

The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were 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 achievable total score is 45 points as all items were available for use.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=11 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores	2.25 score on a scale Standard Deviation 2.09	3.42 score on a scale Standard Deviation 3.18

SECONDARY outcome

Timeframe: 4 weeks

Population: Only a subset of participants completed the questionnaire at 4 weeks

The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were 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 achievable total score is 45 points as all items were available for use.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=11 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores	2.25 score on a scale Standard Deviation 2.09	3.42 score on a scale Standard Deviation 3.18

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire at baseline

The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=11 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Norman Questionnaire (NQ) Scores	3.83 score on a scale Standard Deviation 2.76	4.27 score on a scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire at 4 weeks

The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=11 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Norman Questionnaire (NQ) Scores	2.75 score on a scale Standard Deviation 1.87	4.27 score on a scale Standard Deviation 2.61

SECONDARY outcome

Timeframe: At 4 months

Population: Only a subset of participants completed the questionnaire at 4 months

The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms

Outcome measures

Measure	Manual Lymph Drainage n=7 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=9 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Norman Questionnaire (NQ) Scores	2.71 score on a scale Standard Deviation 1.89	4.56 score on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire at baseline

The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=13 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores	12.40 score on a scale Standard Deviation 16.83	21.45 score on a scale Standard Deviation 18.44

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire at 4 weeks

The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=13 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores	11.20 score on a scale Standard Deviation 16.03	17.62 score on a scale Standard Deviation 18.22

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire 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. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.

Outcome measures

Measure	Manual Lymph Drainage n=11 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=10 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)	47.86 score on a scale Standard Deviation 6.26	44.70 score on a scale Standard Deviation 7.71

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire 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. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.

Outcome measures

Measure	Manual Lymph Drainage n=11 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=10 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)	49.35 score on a scale Standard Deviation 6.40	43.14 score on a scale Standard Deviation 8.44

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire at baseline

The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.

Outcome measures

Measure	Manual Lymph Drainage n=11 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=10 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Physical Function	19.4 score on a scale Standard Deviation 1.0	17.6 score on a scale Standard Deviation 2.6
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Anxiety	6.5 score on a scale Standard Deviation 3.0	6.8 score on a scale Standard Deviation 3.5
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Depression	5.7 score on a scale Standard Deviation 2.3	6.5 score on a scale Standard Deviation 3.5
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Sleep Disturbance	8.6 score on a scale Standard Deviation 3.3	10.0 score on a scale Standard Deviation 2.2
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Roles/Activity	18.1 score on a scale Standard Deviation 2.3	15.1 score on a scale Standard Deviation 3.1
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Pain Interference	4.5 score on a scale Standard Deviation 1.5	7.5 score on a scale Standard Deviation 2.8
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Fatigue	7.0 score on a scale Standard Deviation 2.7	9.6 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire at 4 weeks

The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.

Outcome measures

Measure	Manual Lymph Drainage n=11 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=9 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Roles/Activity	18.5 score on a scale Standard Deviation 2.4	13.9 score on a scale Standard Deviation 3.9
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Pain Interference	4.9 score on a scale Standard Deviation 1.4	7.9 score on a scale Standard Deviation 4.0
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Physical Function	19.8 score on a scale Standard Deviation 0.40	17.2 score on a scale Standard Deviation 3.4
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Anxiety	4.9 score on a scale Standard Deviation 1.3	6.7 score on a scale Standard Deviation 3.0
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Depression	4.5 score on a scale Standard Deviation 1.0	5.1 score on a scale Standard Deviation 2.2
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Fatigue	6.5 score on a scale Standard Deviation 2.8	8.9 score on a scale Standard Deviation 3.2
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) Sleep Disturbance	8.0 score on a scale Standard Deviation 3.1	10.4 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: At Baseline

Population: Only a subset of participants completed the questionnaire at baseline

The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=14 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores	114.3 score on a scale Standard Deviation 21.8	113.6 score on a scale Standard Deviation 21.1

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire at week 4

The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=14 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores	118.4 score on a scale Standard Deviation 14.4	114.7 score on a scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: At baseline

Population: Only a subset of participants completed the assessment at baseline

The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=13 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Body Image Scale (BIS) Score	8.8 score on a scale Standard Deviation 6.6	9.4 score on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: At 4 weeks

Population: Only a subset of participants completed the questionnaire at week 4

The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=13 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Body Image Scale (BIS) Score	7.7 score on a scale Standard Deviation 6.4	9.5 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: At 4 weeks

Satisfaction with treatment will be evaluated at the 4-week assessment using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (FACIT-TSG- Version 4). The FACIT-TSG is a copyrighted 8-item questionnaire, with each item score ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.

Outcome measures

Measure	Manual Lymph Drainage n=12 Participants Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=10 Participants PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores	24.6 score on a scale Standard Deviation 5.9	27.0 score on a scale Standard Deviation 5.2

Adverse Events

Manual Lymph Drainage

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Negative Pressure

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Manual Lymph Drainage n=13 participants at risk Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.	Negative Pressure n=15 participants at risk PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb 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.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/13 • Up to 4 weeks	6.7% 1/15 • Number of events 1 • Up to 4 weeks
Injury, poisoning and procedural complications Elbow Fracture	0.00% 0/13 • Up to 4 weeks	6.7% 1/15 • Number of events 1 • Up to 4 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	7.7% 1/13 • Number of events 1 • Up to 4 weeks	0.00% 0/15 • Up to 4 weeks
General disorders Limb Pain	0.00% 0/13 • Up to 4 weeks	6.7% 1/15 • Number of events 1 • Up to 4 weeks
General disorders Shoulder/Neck Pain	0.00% 0/13 • Up to 4 weeks	6.7% 1/15 • Number of events 1 • Up to 4 weeks

Additional Information

Betty Smoot, DPTSc, PT

University of California, San Francisco

Phone: (707) 494-8262

Email: Betty.Smoot@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place