Trial Outcomes & Findings for Evaluation of BIS for Quantification of Lymphedema (NCT NCT01544335)

Results Overview

Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated in the LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with impedance ratios calculated using the BIS device software.

Recruitment status

COMPLETED

Target enrollment

270 participants

Primary outcome timeframe

5 years

Results posted on

2024-06-27

Participant Flow

270 participants were accrued, however 65 had to be excluded because they later received bilateral breast surgery and 14 withdrew consent. This is why 191 participants started the study.

Participant milestones

Participant milestones
Measure	Bioimpedance Sprectroscopy Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm
Overall Study STARTED	191
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Bioimpedance Sprectroscopy Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm
Overall Study Lost to Follow-up	27
Overall Study Death	4
Overall Study Disease progression	3
Overall Study Baseline Measurements not Available	19

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bioimpedance Spectroscopy n=138 Participants Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm
Age, Categorical <=18 years	0 Participants n=138 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=138 Participants
Age, Categorical >=65 years	27 Participants n=138 Participants
Age, Continuous	53.7 years n=138 Participants
Sex: Female, Male Female	138 Participants n=138 Participants
Sex: Female, Male Male	0 Participants n=138 Participants
Region of Enrollment United States	138 participants n=138 Participants

PRIMARY outcome

Timeframe: 5 years

Population: 53 of the 191 participants had to be excluded. 27 lost to follow up, 4 died on the study, 3 had disease progression, and baseline measurements were not available for 19 participants.

Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated in the LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with impedance ratios calculated using the BIS device software.

Outcome measures

Outcome measures
Measure	Bioimpedance Sprectroscopy n=442 measurements Subjects evaluated using Bioimpedance Spectroscopy Bioimpedance Spectroscopy: BIS used to measure fluid in arm
Correlation of Impedance Ratios Obtained Through Bioimpedance Spectroscopy (BIS) With Perometric Relative Arm Volume Change (RVC)	0.195 correlation coefficient

SECONDARY outcome

Timeframe: 5 years

Population: This data was not collected and outcome cannot be reported.

Relationship among diagnostic criteria pertaining to BIS, perometry, and self-reported symptoms. A change of \>3 Standard Deviations in impedance ratios compared to pre-surgical baseline is considered diagnostic for lymphedema when BIS is utilized. A relative volume change of \>5% - \>10% compared to baseline is considered lymphedema by perometry. Self-report of symptoms including feelings of swelling, heaviness, and tightness are often considered as criteria for lymphedema.

Outcome measures

Outcome data not reported

Adverse Events

Bioimpedance Spectroscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Director, Lymphedema Research Program

Massachusetts General Hospital

Phone: 6177240127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place