Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Fibrocystic Breast Disease

Skin Diseases

An estimate of 255 adult women (≥ 18 years old) who come to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt will be included.

The test with the CELBREA® device will be added to the routine screening according to the protocols of the health facility.

Celbrea

This is an observational, prospective, and transversal study, designed to evaluate the effectiveness of CELBREA® in women from the local community coming to consult at the Breast Pathology Unit of La Paz Hospital (Madrid, Spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt, providing actualized data on the effectiveness of the device within the context of the real-world scenario. Because of its transverse nature, the observation period will be limited to the necessary amount of time to perform the initial consult, additional tests when prescribed by the physician, and the CELBREA® test.

Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)

Observational Prospective Study, to Validate the Effectiveness of CELBREA® Compared to the Detection Results in Symptomatic Women or Those With Diagnostic Doubt (DETECT-BH)

Detection Result (DR): it is defined as the absence or presence of a breast pathology (benign or malignant).

Positive DR: a DR will be labeled as positive (Positive DR) when the presence (diagnosis) of a breast pathology has been verified (benign or malignant).

Negative DR: a DR will be labeled as negative (Negative DR) when the absence of breast pathologies has been verified.

Significant Reading (CELBREA® test): A difference of 4 columns or more between corresponding segments is considered significant.

Non-significant reading (CELBREA® test): a difference of 3 columns or less in any section between corresponding segments is considered non-significant.

Welwaze Medical Inc.

Jose Ignacio Sánchez

Head of Breast Unit - Hospital Universitario La Paz - Madrid - Spain

Nervous System Diseases

Symptoms and General Pathology

Neuralgia

Pain

Mastodynia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.

1 patch was applied topically to the affected site(s) for 12 hours each day.

Lidoderm patch

Placebo patch

This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.

Symptom Management After Breast Cancer Surgery

A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery

Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).

University of California, San Francisco

Lidocaine patch One patch is changed every twenty-four hours

Lidocaine Patch

Placebo patch: Patch is changed every 24 hours

Placebo Patch

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.

Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian/Pacific Islander

Hispanic or Mixed Ethnic Background

Race/Ethnicity, Customized

United States

Region of Enrollment

Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10)

Average pain intensity

Worst pain intensity

Dr. Christine Miaskowski, PI

This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.

Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks

Pain Interference With Function

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)	NCT05857111	Breast Disease Benign Breast D... Breast Cancer	Celbrea	18 Years -	Instituto de Investigación Hospital Universitario La Paz
Symptom Management After Breast Cancer Surgery	NCT00686127	Neuropathic Pai... Postmastectomy ...	Lidoderm patch Placebo patch	18 Years -	University of California, San Francisco
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)	NCT05857111	Breast Disease Benign Breast D... Breast Cancer	Celbrea	18 Years -	Instituto de Investigación Hospital Universitario La Paz
Symptom Management After Breast Cancer Surgery	NCT00686127	Neuropathic Pai... Postmastectomy ...	Lidoderm patch Placebo patch	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for breast symptoms