J Breast Cancer.  2021 Aug;24(4):367-376. 10.4048/jbc.2021.24.e30.

Effect of Poloxamer-Based ThermoSensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial

Affiliations
  • 1Department of Surgery, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
  • 2Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 3Division of Breast Surgery, Department of Surgery, University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
  • 4Department of Surgery, Dankook University College of Medicine, Cheonan, Korea
  • 5Department of General Surgery, Myongji Hospital, Goyang, Korea

Abstract

Purpose
Restricted shoulder motion is a major morbidity associated with a lower quality of life and disability after axillary lymph node dissection (ALND) in patients with breast cancer. This study sought to evaluate the antiadhesive effect of a poloxamer-based thermosensitive sol-gel (PTAS) agent after ALND.
Methods
We designed a double-blind, multicenter randomized controlled study to evaluate the clinical efficacy and safety of PTAS in reducing upper-limb dysfunction after ALND. The primary outcome was the change in the range of motion (ROM) of the shoulder before surgery and 4 weeks after ALND (early postoperative period). Secondary outcomes were shoulder ROM at six months, axillary web syndrome, and lymphedema (late postoperative period).
Results
A total of 170 patients with planned ALND were randomly assigned to one of 2 groups (poloxamer and control) and 15 patients were excluded. In the poloxamer group (n = 76), PTAS was applied to the surface of the operative field after ALND. ALND was performed without the use of poloxamer in the control group (n = 79). Relative to the control group, the poloxamer group had significantly lower early postoperative restrictions in total shoulder ROM at four weeks (−30.04 ± 27.76 vs. −42.59 ± 36.79; p = 0.0236). In particular, the poloxamer group showed greater reductions in horizontal abduction at four weeks (−3.92 ± 9.80 vs. −10.25 ± 15.42; p = 0.0050). The ROM of the shoulder at 24 weeks, axillary web syndrome, and lymphedema were not significantly different between the two groups. No adverse effects were observed in either group.
Conclusion
We suggest that poloxamer might improve the early postoperative shoulder ROM in patients with breast cancer who have undergone ALND.

Keyword

Dissection; Poloxamer; Shoulder
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