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
Open Access
- 23 September 2020
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 15 (9), e0238284
- https://doi.org/10.1371/journal.pone.0238284
Abstract
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. 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. 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. 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. CRISKCT0003386; https://cris.nih.go.kr (20181207)This publication has 41 references indexed in Scilit:
- A Longitudinal Comparison of Arm Morbidity in Stage I–II Breast Cancer Patients Treated with Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy Followed by Completion Lymph Node Dissection, or Axillary Lymph Node DissectionAnnals of Surgical Oncology, 2010
- Upper-body morbidity following breast cancer treatment is common, may persist longer-term and adversely influences quality of lifeHealth and Quality of Life Outcomes, 2010
- Longitudinal change of treatment‐related upper limb dysfunction and its impact on late dysfunction in breast cancer survivors: A prospective cohort studyJournal of Surgical Oncology, 2009
- Barriers to rehabilitation following surgery for primary breast cancerJournal of Surgical Oncology, 2007
- Upper-Extremity Pain Disorders in Breast CancerArchives of Physical Medicine and Rehabilitation, 2006
- Chronic Arm Morbidity After Curative Breast Cancer Treatment: Prevalence and Impact on Quality of LifeJournal of Clinical Oncology, 2002
- Quality of Life in Breast Cancer Survivors as Identified by Focus GroupsPsycho‐Oncology, 1997
- Limitations in upper-body strength associated with breast cancer: A comparison of black and white womenJournal of Clinical Epidemiology, 1996
- The impact on quality of life by radiation late effectsInternational Journal of Radiation Oncology*Biology*Physics, 1995
- The effect of pre- and postmastectomy radiotherapy on the degree of edema, shoulder-joint mobility, and gripping forceCancer, 1981