Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment
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|ClinicalTrials.gov Identifier: NCT03083314|
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD) Procedure: COMPLETE AXILLARY DISSECTION (ALND)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The proposed study is a 2-arm (1:1 allocation) prospective randomised trial. The control arm consists of patients randomized to ALND, the study arm is patients randomized to SAD.|
|Masking:||None (Open Label)|
|Official Title:||SELECTIVE AXILLARY LYMPH NODE DISSECTION VS COMPLETE AXILLARY DISSECTION: A RANDOMISED CLINICAL TRIAL TO ASSESS THE PREVENTION OF LYMPHEDEMA IN BREAST CANCER TREATMENT|
|Actual Study Start Date :||June 12, 2014|
|Estimated Primary Completion Date :||June 2, 2017|
|Estimated Study Completion Date :||June 2, 2017|
|Experimental: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)||
Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
|Active Comparator: COMPLETE AXILLARY DISSECTION (ALND)||
Procedure: COMPLETE AXILLARY DISSECTION (ALND)
- To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND) [ Time Frame: 36 months ]For this purpose patients enrolled will receive a physical assessment one month after surgery, with evaluation at 6 and 12 months after surgery that includes oncological assessment, physical assessment, lymphoscintigraphy, and self-evaluation questionnaire to assess the presence BCRL.
- Safety of the selective axillary dissection (SAD) procedure by assessing the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes. [ Time Frame: 36 months ]to assess the potential for residual disease in the axilla after SAD by evaluating the status, in the ALND arm, of nodes that are spared and assess the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes.
- To compare costs in the axillary lymph node dissection (ALND) and selective axillary dissection (SAD) arms [ Time Frame: 36 months ]To compare costs in the ALND and SAD arms including: lymphoscintigraphy, time required for surgery, and treatments required for lymphedema during follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083314
|Contact: Massimiliano Gennaro, MDfirstname.lastname@example.org|
|Milan, Italy, 20133|
|Contact: Massimiliano Gennaro, MD +390223903246 email@example.com|