Abstract
BackgroundChemotherapy-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.MethodsThis 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.DiscussionIt 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 registrationClinical Research Information Service (CRIS), Republic of Korea, ID: KCT0002357. Registered retrospectively on 13 June 2017.
Highlights
Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and sometimes irreversible neurotoxic symptom that occurs in 30–40% of chemotherapy-treated cancer patients
It is expected that the combination of a low-frequency electrostimulation device and pharmacological intervention will produce synergistic effects in breast cancer patients with CIPN after treatment
According to the latest national cancer statistics, the prevalence rate of breast cancer in Korea has increased more than three times in the past 10 years and the 5-year cancer survival rates have increased from 77.9% in 1993–1998 to 91.5% in 2008–2013 [1, 2]
Summary
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. 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. HRQOL has been perceived as an important clinical outcome for long-term survivorship among women living longer with cancer For this reason, the balance between survival advantages from curative therapy and HRQOL challenges has received special attention from healthcare professionals as well as breast cancer patients. Anticancer treatment, especially chemotherapy, was associated with acute or late toxicities which affected post-treatment HRQOL after treatment [5, 6]
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