Effect of Poloxamer-Based ThermoSensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial
- Author:
Hee Jun CHOI
1
;
Jai Min RYU
;
Byung Joo CHAE
;
Eun-Kyu KIM
;
Jun Won MIN
;
Hyuk Jai SHIN
;
Seok Jin NAM
;
Jonghan YU
;
Jeong Eon LEE
;
Se Kyung LEE
;
Seok Won KIM
Author Information
- Publication Type:Original Article
- From:Journal of Breast Cancer 2021;24(4):367-376
- CountryRepublic of Korea
- Language:English
-
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.
