Parenteral Hydration in Patients With Advanced Cancer: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial

Purpose The vast majority of patients with cancer at the end of life receive parenteral hydration in hospitals and no hydration in hospice, with limited evidence supporting either practice. In this randomized controlled trial, we determined the effect of hydration on symptoms associated with dehydration, quality of life, and survival in patients with advanced cancer. Patients and Methods We randomly assigned 129 patients with cancer from six hospices to receive parenteral hydration (normal saline 1 L per day) or placebo (normal saline 100 mL per day) daily over 4 hours. The primary outcome was change in the sum of four dehydration symptoms (fatigue, myoclonus, sedation and hallucinations, 0 = best and 40 = worst possible) between day 4 and baseline. Secondary outcomes included Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS), Nursing Delirium Screening Scale (NuDESC), Unified Myoclonus Rating Scale (UMRS), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), Dehydration Assessment Scale, creatinine, urea, and overall survival. Intention-to-treat analysis was conducted to examine the change by day 4 ± 2 and day 7 ± 2 between groups. Results The hydration (n = 63) and placebo (n = 66) groups had similar baseline characteristics. We found no significant differences between the two groups for change in the sum of four dehydration symptoms (−3.3 v −2.8, P = .77), ESAS (all nonsignificant), MDAS (1 v 3.5, P = .084), NuDESC (0 v 0, P = .13), and UMRS (0 v 0, P = .54) by day 4. Results for day 7, including FACIT-F, were similar. Overall survival did not differ between the two groups (median, 21 v 15 days, P = .83). Conclusion Hydration at 1 L per day did not improve symptoms, quality of life, or survival compared with placebo.

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Parenteral hydration (PH) in advanced cancer patients: A multi-center, double-blind, placebo-controlled randomized trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9025 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9025-9025 ◽

Cited By ~ 1

Author(s):

Shalini Dalal ◽

David Hui ◽

Isabel Torres-Vigil ◽

J. Lynn Palmer ◽

Julio Allo ◽

...

Keyword(s):

Quality Of Life ◽

Overall Survival ◽

Cancer Patients ◽

Advanced Cancer ◽

Normal Saline ◽

Rating Scale ◽

Assessment Scale ◽

Rank Test ◽

Edmonton Symptom Assessment Scale

9025 Background: The vast majority of cancer patients at the end of life receive PH in hospitals and no PH in hospice. There is limited evidence supporting either practice. Our preliminary study suggested that PH (1L/day) improved dehydration symptoms (Bruera et al. JCO 2005). In this randomized controlled trial, we determined the effect of PH on symptoms associated with dehydration, quality of life and survival for patients with advanced cancer. Methods: We randomly assigned 129 cancer patients from 6 hospices to receive subcutaneous PH (normal saline 1 L/day) or placebo (normal saline 100 mL/day) daily over 4 hours. The primary outcome was change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations, 0=best and 40=worst possible) between day 4 and baseline. Secondary outcomes included Edmonton Symptom Assessment Scale (ESAS), Memorial delirium assessment scale [MDAS], Nursing delirium screening scale [NuDESC], unified myoclonus rating scale [UMRS], FACIT-F, creatinine, urea, and overall survival. Intention-to-treat analysis was conducted to examine the change in each variable between baseline and day 4 or day 7. Log rank test was used for survival analysis. Results: Mean age was 67 (range 43-92), female 61%, Caucasians 60%, gastrointestinal, genitourinary and lung cancers 70%, performance status 3-4 113 (88%), with no baseline differences between the hydration (N=63) and placebo (N=66) groups. No significant differences were found between the hydration and placebo groups for the sum of 4 dehydration symptoms (-3.3 v. -2.8, p=0.77), ESAS (all non-significant), MDAS (1 vs. 3.5, p=0.084), NuDESC (0 v. 0, p=0.13) and UMRS (0 vs. 0, p=0.54). We also did not identify any group differences for day 7, except for a decrease in urea level in the hydration group (-2 vs. 2, P=0.02). Median overall survival was 21 days for PH and 15 days for placebo (p=0.83). Conclusions: PH at 1 L/day did not improve symptoms, quality of life or survival compared to placebo. Further studies are required to determine if any subgroups would benefit from PH.

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Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2012.43.6766 ◽

2013 ◽

Vol 31 (10) ◽

pp. 1271-1276 ◽

Cited By ~ 50

Author(s):

Egidio Del Fabbro ◽

Rony Dev ◽

David Hui ◽

Lynn Palmer ◽

Eduardo Bruera

Keyword(s):

Quality Of Life ◽

Weight Loss ◽

Advanced Cancer ◽

Interim Analysis ◽

Null Hypothesis ◽

Controlled Trial ◽

Double Blind ◽

Patients With Cancer ◽

Edmonton Symptom Assessment Scale

Purpose Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. Patients and Methods We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056). Results After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28. Conclusion In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.

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The effect of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9062 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9062-9062

Author(s):

Egidio Del Fabbro ◽

Rony Dev ◽

David Hui ◽

J. Lynn Palmer ◽

Eduardo Bruera

Keyword(s):

Quality Of Life ◽

Weight Loss ◽

Advanced Cancer ◽

Interim Analysis ◽

Controlled Trial ◽

Well Being ◽

Test Statistic ◽

Double Blind ◽

Edmonton Symptom Assessment Scale

9062 Background: Patients with advanced cancer experience anorexia and weight loss which impairs their quality of life. Prior studies suggest melatonin, a frequently used integrative medicine may attenuate weight loss, anorexia, fatigue, and depression. These studies were limited by a lack of blinding and absence of placebo controls. The primary objective of this study was to compare melatonin to placebo for appetite in patients with cachexia. Methods: A randomized, double-blind, 28 day trial of melatonin 20mg vs. placebo in patients with advanced lung or gastrointestinal cancer, appetite scores >3 on a 0 to 10 scale (10 = worst appetite) and a history of weight loss ≥ 5% within 6 months. Patients unable to maintain oral intake, thyroid or adrenal dysfunction, or with a karnofsky <40 were excluded from the study. The assessments included weight, symptom severity by Edmonton Symptom Assessment Scale (ESAS) and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).Differences between groups from baseline to day 28 were analyzed using one-sided two sample t tests (appetite, pain and well-being) or Wilcoxon two-sample tests for the other variables. Interim analysis at half point had a Lan-DeMets monitoring boundary with an O’Brien-Fleming stopping rule. The decision boundaries for the interim test was to accept the null hypothesis of no treatment difference (futility) if the test statistic Z < 0.39 (p ≥ 0.348). Results: After interim analysis of 48 patients, the study was closed by the Data Safety Monitoring Board for futility. There were no significant differences between groups in appetite (p=0.78), weight (p= 0.17), FAACT score (p=0.95), insomnia (p=0.62) or other symptoms measured by the ESAS from baseline to day 28.No significant toxicities were observed. Conclusions: In cachectic patients with advanced cancer, 20mg oral Melatonin at night does not improve appetite, weight or quality of life compared to placebo.

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Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: A preliminary double-blind placebo-controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e19643 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e19643-e19643

Author(s):

Kalyan Pulivarthi ◽

Rony Dev ◽

Jose Garcia ◽

J. Lynn Palmer ◽

Eduardo Bruera ◽

...

Keyword(s):

Quality Of Life ◽

Advanced Cancer ◽

Controlled Trial ◽

Depression Scale ◽

T Test ◽

Testosterone Replacement ◽

Double Blind ◽

Significant Difference ◽

Edmonton Symptom Assessment Scale

e19643 Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.

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Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD

Journal of Attention Disorders ◽

10.1177/1087054717723984 ◽

2017 ◽

Vol 23 (13) ◽

pp. 1578-1591 ◽

Cited By ~ 7

Author(s):

David R. Coghill ◽

Alain Joseph ◽

Vanja Sikirica ◽

Mark Kosinski ◽

Caleb Bliss ◽

...

Keyword(s):

Quality Of Life ◽

Children And Adolescents ◽

Rating Scale ◽

Controlled Trial ◽

Pearson Correlation ◽

Correlation Coefficients ◽

Parent Report ◽

Functional Impairments ◽

Risk Avoidance

Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Achievement and Risk Avoidance ( r ≈ .4), but weakly with Resilience, Satisfaction, and Comfort ( r ≈ .2); and moderately with Weiss Functional Impairment Rating Scale–Parent (WFIRS-P) total score ( r ≈ .5). CHIP-CE:PRF Achievement and Risk Avoidance correlated moderately to strongly with WFIRS-P total score ( r ≈ .6). Conclusion: The ADHD-RS-IV, CHIP-CE:PRF, and WFIRS-P capture distinct but interconnected aspects of treatment response in individuals with ADHD.

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The ‘Cancer Home-Life Intervention’: A randomised controlled trial evaluating the efficacy of an occupational therapy–based intervention in people with advanced cancer

Palliative Medicine ◽

10.1177/0269216317747199 ◽

2018 ◽

Vol 32 (4) ◽

pp. 744-756 ◽

Cited By ~ 5

Author(s):

Marc Sampedro Pilegaard ◽

Karen la Cour ◽

Lisa Gregersen Oestergaard ◽

Anna Thit Johnsen ◽

Line Lindahl-Jacobsen ◽

...

Keyword(s):

Quality Of Life ◽

Advanced Cancer ◽

Controlled Trial ◽

Health Related Quality ◽

Home Life ◽

Everyday Activities ◽

Related Quality ◽

Health Related ◽

Randomised Controlled

Background: People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the ‘Cancer Home-Life Intervention’. Aim: To evaluate the efficacy of the ‘Cancer Home Life-Intervention’ compared with usual care with regard to patients’ performance of, and participation in, everyday activities, and their health-related quality of life. Design and intervention: A randomised controlled trial ( ClinicalTrials.gov NCT02356627). The ‘Cancer Home-Life Intervention’ is a brief, tailored, occupational therapy–based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. Setting/participants: Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. Results: A total of 242 participants were randomised either to the intervention group ( n = 121) or the control group ( n = 121). No effect was found on the primary outcome (between-group mean change: −0.04 logits (95% confidence interval: −0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. Conclusion: In most cases, the ‘Cancer Home-Life Intervention’ was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants’ everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.

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Intensive versus minimalist follow-up in patients treated for endometrial cancer: A multicentric randomized controlled trial (The TOTEM study—NCT00916708).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.5506 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 5506-5506

Author(s):

Paolo Zola ◽

Giovannino Ciccone ◽

Elisa Piovano ◽

Luca Fuso ◽

Elena Peirano ◽

...

Keyword(s):

Quality Of Life ◽

Overall Survival ◽

Endometrial Cancer ◽

Cancer Patients ◽

Early Recognition ◽

Controlled Trial ◽

Physical And Mental Health ◽

Randomized Controlled

5506 Background: Intensive follow-up in cancer patients, which absorbs a lot of health system resources and can be a source of increased stress for patients, are often proposed on the assumption that an early recognition of relapse will translate in better outcomes. In endometrial cancer few randomized controlled trials were conducted to assess the role of a reduced number of the scheduled visits and of different settings of the follow-up, but did not investigate the contribution of routine serum, cytological or imaging follow-up investigations in improving overall survival or quality of life. The TOTEM study was planned to compare an intensive (INT) vs minimalist (MIN) 5- year follow-up regimen in endometrial cancer patients in terms of overall survival (OS). Methods: Patients surgically treated for endometrial cancer, in complete clinical remission confirmed by imaging, FIGO stage I-IV, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The main study hypothesis was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR = 0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS), health-related quality of life (HRQL) assessed at baseline, at 6 and 12 months and then yearly (with the SF-12 Physical and Mental Health Summary Scale) and costs. Results: 1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis (60% LoR). Compliance with the follow-up scheduled visits was 75.3%, similar between INT (74.7%) and MIN (75.9%) arms, whereas the mean number of recorded exams (laboratory or imaging) was markedly higher in the INT than in the MIN arms (9.7 vs 2.9, p < 0.0001). After a median follow-up of 66 months, the overall 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR = 1.12, 95%CI 0.85-1.48, p = 0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR = 1.48, 0.92-2.37, p = 0.104) in the LoR and 85.3% and 84.7% (HR = 0.96, 0.68-1.36, p = 0.814) in the HiR group. No relevant differences emerged in RFS between INT and MIN regimens, (HR = 1.13, 0.87-1.48, p = 0.365). At the time of the relapse most women were asymptomatic (146/228, 64.0%), with a tendency of higher proportions in the INT than in the MIN arm, both in the LoR group (78.8% vs 61.1%, p = 0.070) and in the HiR one (64% vs 60%, p = 0.754). HRQL was available only for a subgroup of patients (50% at baseline) and did not differ between arms. Conclusions: Intensive follow-up in endometrial cancer treated patients showed a weak and uncertain advantage in detecting earlier asymptomatic relapses but did not improve OS, even in HiR patients, nor influenced HRQL. Frequent routine use of imaging and laboratory exams in these patients should be discouraged. Clinical trial information: NCT00916708.

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Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Trials ◽

10.1186/s13063-020-04759-4 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Yongcan Wu ◽

Caixia Pei ◽

Xiaomin Wang ◽

Mingjie Wang ◽

Demei Huang ◽

...

Keyword(s):

Quality Of Life ◽

Intestinal Microbiota ◽

Rating Scale ◽

Short Form ◽

Controlled Trial ◽

High Exposure ◽

Gastrointestinal Symptom Rating Scale ◽

Probiotic Treatment ◽

High Concentrations

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.

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Impacting Quality of Life for Patients With Advanced Cancer With a Structured Multidisciplinary Intervention: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2006.06.209 ◽

2006 ◽

Vol 24 (4) ◽

pp. 635-642 ◽

Cited By ~ 227

Author(s):

Teresa A. Rummans ◽

Matthew M. Clark ◽

Jeff A. Sloan ◽

Marlene H. Frost ◽

John Michael Bostwick ◽

...

Keyword(s):

Quality Of Life ◽

Radiation Therapy ◽

Advanced Cancer ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Analog Scale ◽

Multidisciplinary Intervention ◽

Linear Analog

Purpose The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and Methods Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

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A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy

Integrative Cancer Therapies ◽

10.1177/1534735420925519 ◽

2020 ◽

Vol 19 ◽

pp. 153473542092551

Author(s):

Si-Yeon Song ◽

Ji-Hye Park ◽

Jin Sun Lee ◽

Je Ryong Kim ◽

Eun Hee Sohn ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Peripheral Neuropathy ◽

Rating Scale ◽

Controlled Trial ◽

Low Frequency ◽

Pharmacological Intervention ◽

European Organization ◽

Eortc Qlq

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group ( P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.

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