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KMID : 1134120210240040367
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Journal of Breast Cancer
2021 Volume.24 No. 4 p.367 ~ p.376
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Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial
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Choi Hee-Jun
Ryu Jai-Min
Chae Byung-Joo
Kim Eun-Kyu
Min Jun-Won
Shin Hyuk-Jai
Nam Seok-Jin
Yu Jong-Han
Lee Jeong-Eon
Lee Se-Kyung
Kim Seok-Won
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Abstract
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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.
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KEYWORD
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Dissection, Poloxamer, Shoulder
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