Lymphedema, Breast Cancer
Conditions
Keywords
Enhanced Lymphedema
Brief summary
This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Diagnostic procedures, such as bioimpedance spectroscopy, may allow doctors to find and diagnose lymphedema earlier than arm circumference measurement alone.
Detailed description
PRIMARY OBJECTIVES: I. To test, in a randomized controlled trial, the ability of the enhanced lymphedema (LE) detection program (ELED) versus arm circumference alone to detect early/reversible LE. II. To compare the severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, between the two detection modalities. III. To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement/bioimpedance spectroscopy (BIS) difference. IV. To compare the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment between the enhanced vs. standard detection groups. V. To determine compliance with LE preventive care and treatment. Patients are randomized to 1 of 2 arms: those undergo arm circumference measurement only and those undergoing undergo arm circumference measurement and bioimpedance spectroscopy. Measurements taken at 4, 10, 16, 22, 28, and 34 months. In both arms, if lymphedema is diagnosed, patients are given a compression garment to wear daily for 6 weeks. If lymphedema does not improve after 6 weeks, patients undergo complete decongestive therapy over approximately 1 hour three times a week. Patients complete remedial exercises comprising active, repetitive range of motion of the involved extremity and light aerobic conditioning until extremity volume stabilizes or improves. Patients are also instructed to perform exercises at home. After completion of study, patients diagnosed with lymphedema are followed up for 1 year.
Interventions
PROCEDUREarm circumference measurement
Undergo arm circumference measurement
bioimpedance spectroscopy
Sponsors
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with stage I-III cancer of the female breast * Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy as well as before surgery * Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy as well as before surgery * Patients with a history of other invasive malignancies are eligible as long as they have no evidence of disease 5 years post-diagnosis * Patients with basal cell and squamous cell cancer of the skin are eligible * Patients willing to return to the study site for the duration of the study (34 months)
Exclusion criteria
* Pregnant women * Patients who are homebound or dependent upon a walker or wheelchair for mobility * Patients diagnosed enhanced lymphedema * Hypertensive patients who are using diuretics * Documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years * Prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Enhanced Lymphedema Detection | During treatment (Up to 34 months) | 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.\*\*\* |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Enhanced Lymphedema | During treatment (Up to 34 months) | 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. |
| Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema | During treatment (up to 34 months) plus 1 year post treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was terminated due to PI departure | 95 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Rates of Enhanced Lymphedema Detection
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.\*\*\*
Time frame: 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.\*\*\*
Secondary
Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema
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.
Time frame: During treatment (up to 34 months) plus 1 year post treatment
Population: \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
Secondary
Severity of Enhanced Lymphedema
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.
Time frame: 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.\*\*\*