PLoS ONE (Jan 2020)

The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.

  • Sae Byul Lee,
  • Sung-Chan Gwark,
  • Cheol Min Kang,
  • Guiyun Sohn,
  • Jisun Kim,
  • Il Yong Chung,
  • Jong Won Lee,
  • Hee Jeong Kim,
  • Beom Seok Ko,
  • Sei-Hyun Ahn,
  • Won Kim,
  • Junghwa Do,
  • Jae Yong Jeon,
  • Jinsung Kim,
  • Eunhae Um,
  • Tae In Yoon,
  • Sung-Ui Jung,
  • Minkyu Han,
  • Byung Ho Son

DOI
https://doi.org/10.1371/journal.pone.0238284
Journal volume & issue
Vol. 15, no. 9
p. e0238284

Abstract

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PurposeRestricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer.MethodsWe conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer.ResultsA total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group.ConclusionsThe results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion.Trial registrationCRISKCT0003386; https://cris.nih.go.kr (20181207).