The aim of this clinical study was to evaluate quality of life (QoL) in early-stage breast cancer patients and to investigate the effects of a comprehensive rehabilitation program comparing women undergoing sentinel node biopsy (SNB) versus complete axillary lymph node dissection (ALND). QoL was assessed with the Functional Assessment of Cancer Therapy--General and Functional Assessment of Cancer Therapy--Breast (FACT-B) questionnaire. Eighty-nine women with histologically confirmed primary breast cancer stages I-II were enrolled. Recruitment began on May 2006 and ended on December 2007. According to current standards of care, 58 women were found clinically fit to undergo SNB, and the other 31 were elected for ALND. Thirty women who underwent SNB were randomly allocated to participate in a comprehensive postoperative rehabilitation program, and the 28 remaining were dismissed and scheduled to return for clinical follow-up. Women undergoing ALND had a better QoL within 30 days of surgery on the FACT-B, FACT-G, Trial Outcome Index (TOI), emotional well-being (EWB), and breast concern subscale (BCS) (P < .005) and at 6 months after surgery on the EWB subscale only. Women undergoing SNB had a significant improvement in QoL only on the EWB subscale 6 months after surgery in the group with rehabilitation and 30 days after surgery in the group without rehabilitation. Women undergoing ALND benefited from a rehabilitation program and had a better QoL. Women undergoing BLS, regardless of rehabilitation, showed improvement in QoL for the emotional well-being subscale only.153342-9