The evaluation of changes in peripheral neuropathy and quality-of-life using low-frequency electrostimulation in patients treated with chemotherapy for breast cancer: a study protocol.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and sometimes irreversible neurotoxic symptom that occurs in 30-40% of chemotherapy-treated cancer patients. CIPN negatively affects both the patient's abilities to perform daily activities and their health-related quality of life (HRQOL) after chemotherapy treatment. Although this neuropathy has been treated with duloxetine and/or gabapentin, limited therapeutic benefits have been reported, thereby necessitating the development of an integrated approach that combines pharmacological management and complementary methods such as acupuncture and electric nerve stimulation. Therefore, this study is designed to examine the effect of a portable, low-frequency electrostimulation (ES) device on CIPN symptoms and HRQOL of female patients diagnosed with CIPN immediately after chemotherapy for breast cancer. METHODS: This study is a single-center, randomized, placebo-controlled trial with two parallel groups and a 2-week follow-up. We will enroll 80 breast cancer patients who are newly diagnosed with CIPN after chemotherapy. Duloxetine or pregabalin will be prescribed to all participants from the initial assessment. Half of the patients will be assigned into the experimental group and the other half to the control group. The CarebandR (Piomed Inc., Seoul, Korea), a wearable wristband that generates low-frequency electrostimulation, will be administered only to the experimental group. Electrostimulation will be administered on the unilateral PC6 acupoint. A numerical rating scale will be used to assess the overall intensity of CIPN symptoms. The key secondary outcome variables include patient-reported CIPN symptom distress tested by a self-rated questionnaire, physician-rated symptom severity assessed by the Total Neuropathy Score, and HRQOL. DISCUSSION: It is expected that the combination of a low-frequency electrostimulation device and pharmacological intervention (duloxetine or pregabalin) will produce synergistic effects in breast cancer patients with CIPN after treatment. To our knowledge, this is the first study to investigate the beneficial effect of a new integrated approach for CIPN management after breast cancer treatment. The study findings can expand our knowledge and understanding of the occurrence of CIPN and the efficacy of integrated intervention efforts to ameliorate CIPN symptoms. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, ID: KCT0002357 . Registered retrospectively on 13 June 2017.

Modified intracorporeal gastroduodenostomy in totally laparoscopic distal gastrectomy for gastric cancer: early experience.

PURPOSE: This study presents findings on the clinical usefulness of an overlap method that is another modification for the currently well-known intracorporeal gastroduodenostomy in totally laparoscopic distal gastrectomy (TLDG). METHODS: We studied 42 patients diagnosed with gastric cancer who underwent TLDG between December 2011 and March 2013. Endoscopic linear staplers were used for intracorporeal anastomosis and patients were observed with endoscopic tracking six months after surgery. We retrospectively reviewed the outcome of the operation, the clinical pathological results, and the endoscopy results. RESULTS: The mean duration of the operation for 42 patients was 228.3 ± 42.5 minutes and the mean time to complete the anastomosis was 12.18 ± 2.3 minutes. There were no mortalities and no cases of open conversion. Following the operation, 37 patients had stage IA, 5 in stage IB, and 3 in stage II gastric cancer. Abscesses were seen in 3 patients and 5 cases of stasis during the postoperative period. Duodenoscopy 6 months after the operation showed 11 cases of gastric stasis, 28 cases of bile reflux, and 1 new case of erosive gastritis. We did not observe contraction in any of the patients. CONCLUSION: The overlap method for intracorporeal gastroduodenostomy, using an endoscopic linear stapler, can be considered a feasible and safe technique for the treatment of stomach cancer. However, a long-term comparative study is required to sufficiently evaluate our findings.