1. 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
- Author
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Sei Hyun Ahn, Junghwa Do, Jong Won Lee, Tae In Yoon, Beom Seok Ko, Sung-ui Jung, Eunhae Um, Minkyu Han, Hee Jeong Kim, Il Yong Chung, Cheol Min Kang, Byung Ho Son, Sae Byul Lee, Jisun Kim, Jin Sung Kim, Guiyun Sohn, Won Gu Kim, Sung-chan Gwark, and Jae Yong Jeon
- Subjects
Cancer Treatment ,Pilot Projects ,law.invention ,0302 clinical medicine ,Medical Conditions ,Randomized controlled trial ,law ,Breast Tumors ,Medicine and Health Sciences ,030212 general & internal medicine ,Prospective Studies ,Hyaluronic Acid ,Range of Motion, Articular ,Prospective cohort study ,Musculoskeletal System ,Mastectomy ,Multidisciplinary ,Middle Aged ,Prognosis ,Arms ,Drug Combinations ,medicine.anatomical_structure ,Lymphedema ,Surgical Oncology ,Oncology ,030220 oncology & carcinogenesis ,Lymphatic Metastasis ,Medicine ,Female ,Anatomy ,Range of motion ,Research Article ,Clinical Oncology ,medicine.medical_specialty ,Shoulder ,Science ,Disabilities ,Pain ,Surgical and Invasive Medical Procedures ,Breast Neoplasms ,Poloxamer ,03 medical and health sciences ,Surface-Active Agents ,Breast cancer ,Signs and Symptoms ,Double-Blind Method ,Breast Cancer ,medicine ,Humans ,Adverse effect ,business.industry ,Axillary Lymph Node Dissection ,Biology and Life Sciences ,Cancers and Neoplasms ,medicine.disease ,Surgery ,Axilla ,Shoulders ,Body Limbs ,Carboxymethylcellulose Sodium ,Case-Control Studies ,Lymph Node Excision ,Clinical Medicine ,business ,Follow-Up Studies - Abstract
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).
- Published
- 2020