Trial Outcomes & Findings for Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer (NCT NCT03648983)
NCT ID: NCT03648983
Last Updated: 2018-10-01
Results Overview
Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models. \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
TERMINATED
NA
95 participants
During treatment (Up to 34 months)
2018-10-01
Participant Flow
Participant milestones
| Measure |
Study Population
Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
|
|---|---|
|
Overall Study
STARTED
|
95
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
| Measure |
Study Population
Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.
|
|---|---|
|
Overall Study
Study was terminated due to PI departure
|
95
|
Baseline Characteristics
Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: During treatment (Up to 34 months)Population: \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models. \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During treatment (Up to 34 months)Population: \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
Severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During treatment (up to 34 months) plus 1 year post treatmentPopulation: \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
The Fisher's exact test will be used to compare between the enhanced vs. standard detection groups the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment. Logistic regression models will also be fit to the data to adjust for potential confounders.
Outcome measures
Outcome data not reported
Adverse Events
Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place