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.
<h4>Purpose</h4>Restricted 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 (A...
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Public Library of Science (PLoS)
2020-01-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Sae Byul Lee |
| collection | DOAJ |
| description | <h4>Purpose</h4>Restricted 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.<h4>Methods</h4>We 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.<h4>Results</h4>A 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.<h4>Conclusions</h4>The 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.<h4>Trial registration</h4>CRISKCT0003386; https://cris.nih.go.kr (20181207). |
| format | Article |
| id | doaj-art-ebfccc07e7db4308ba2a9ef8d2bbc2d5 |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj-art-ebfccc07e7db4308ba2a9ef8d2bbc2d52025-08-20T03:53:38ZengPublic Library of Science (PLoS)PLoS ONE1932-62032020-01-01159e023828410.1371/journal.pone.0238284The 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 LeeSung-Chan GwarkCheol Min KangGuiyun SohnJisun KimIl Yong ChungJong Won LeeHee Jeong KimBeom Seok KoSei-Hyun AhnWon KimJunghwa DoJae Yong JeonJinsung KimEunhae UmTae In YoonSung-Ui JungMinkyu HanByung Ho Son<h4>Purpose</h4>Restricted 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.<h4>Methods</h4>We 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.<h4>Results</h4>A 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.<h4>Conclusions</h4>The 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.<h4>Trial registration</h4>CRISKCT0003386; https://cris.nih.go.kr (20181207).https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0238284&type=printable |
| spellingShingle | 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 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. PLoS ONE |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | effects of poloxamer and sodium alginate mixture guardix sg r on range of motion after axillary lymph node dissection a single center prospective randomized double blind pilot study |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0238284&type=printable |
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