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      Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer

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          Abstract

          Purpose

          Women with breast cancer may experience symptoms of depression, anxiety, pain, fatigue and sleep disturbances during chemotherapy. However, there are few modalities that address multiple, commonly occurring symptoms that may occur in individuals receiving cancer treatment. Cranial electrical stimulation (CES) is a treatment that is FDA cleared for depression, anxiety and insomnia. CES is applied via electrodes placed on the ear that deliver pulsed, low amplitude electrical current to the head.

          Methods

          This phase III randomized, sham-controlled study aimed to examine the effects of cranial microcurrent stimulation on symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Patients were randomly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinicaltrials.gov, NCT00902330.

          Results

          The sample included N = 167 women with early-stage breast cancer. Symptom severity of depression, anxiety, and fatigue and sleep disturbances were generally mild to moderate. Levels of pain were low. Anxiety was highest prior to the initial chemotherapy and decreased over time. The primary outcome assessment (symptoms of depression, anxiety, fatigue, pain, sleep disturbances) revealed no statistically significant differences between the two groups, actual CES vs. sham.

          Conclusion

          In this study, women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range. Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer, further symptom management modalities should be evaluated to mitigate symptoms of depression, anxiety, fatigue, pain and sleep disturbances over the course of chemotherapy.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s40064-015-1151-z) contains supplementary material, which is available to authorized users.

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          Most cited references22

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          Breast cancer survivors at work.

          Jørgen Olsen, Michael Feuerstein, Peter Hansen … (2008)
          Residual symptoms such as fatigue, cognitive limitations, and emotional distress can be experienced by cancer survivors. These symptoms may impact their abilities at work. It is unclear to what degree these symptoms are associated with work in occupationally active breast cancer survivors, the most prevalent cancer survivor group. A sample of 100 women working part- or full-time with a history of breast cancer and a noncancer comparison group (n = 103) completed questionnaires related to physical fatigue, depression, anxiety, and cognitive limitations. Demographic variables, job stress, type of job, stage at diagnosis, treatment exposure, and health behaviors were also measured as potential confounders. Four years postdiagnosis breast cancer survivors reported higher levels of age-adjusted work limitations (F = 32.708, P < 0.001). Significant group by fatigue (beta = -0.311, 95% CI = -0.545 to -0.076) and group by depression (beta = 0.331, 95% CI = 0.024 to 0.638) interactions were observed. Fatigue was more strongly related to work limitations in the cancer survivor group whereas depressive symptoms were more strongly related to limitations at work in the noncancer group. Although fatigue accounted for 22% of the variance in the model, it explained 71% of the contribution of symptom burden to the overall model. Fatigue was more strongly related to work in the breast cancer survivor group after accounting for many potential confounders. There is a pressing need to better understand and effectively manage fatigue in the workplace in occupationally active breast cancer survivors.
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            Effect of paroxetine hydrochloride (Paxil) on fatigue and depression in breast cancer patients receiving chemotherapy.

            Raman Qazi, Joseph A Roscoe, J Hickok … (2005)
            Fatigue can significantly interfere with a cancer patient's ability to fulfill daily responsibilities and enjoy life. It commonly co-exists with depression in patients undergoing chemotherapy, suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue. We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy randomly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor (SSRI) paroxetine (Paxil, SmithKline Beecham Pharmaceuticals) or an identical-appearing placebo. Patients began their study medication seven days following their first on-study treatment and continued until seven days following their fourth on-study treatment. Seven days after each treatment, participants completed questionnaires measuring fatigue (Multidimensional Assessment of Fatigue, Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist) and depression (Profile of Mood States-Depression subscale [POMS-DD] and Center for Epidemiologic Studies-Depression [CES-D]). Repeated-measures ANOVAs, after controlling for baseline measures, showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D (p = 0.006) and the POMS-DD (p = 0.07) but not in reducing fatigue (all measures, ps > 0.27). Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo, indicating that a biologically active dose was used, no significant differences between groups on any of the measures of fatigued were observed. Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment.
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              Fatigue in women receiving adjuvant chemotherapy for breast cancer: characteristics, course, and correlates.

              Bradley Hann, Travis Horton, P. Jacobsen … (1999)
              This study investigated the characteristics, course, and correlates of fatigue in women receiving adjuvant chemotherapy for breast cancer. Fifty-four patients were assessed before the start of chemotherapy and during the first three treatment cycles. An age-matched sample of women with no cancer history was assessed at similar time intervals for comparison purposes. Results indicated that breast cancer patients experienced worse fatigue than women with no cancer history. These differences were evident before and after patients started chemotherapy. In addition, fatigue worsened among patients after treatment started. More severe fatigue before treatment was associated with poorer performance status and the presence of fatigue-related symptoms (e.g., sleep problems and muscle weakness). Increases in fatigue after chemotherapy started were associated with continued fatigue-related symptoms and the development of chemotherapy side effects (e.g., nausea and mouth sores). These findings demonstrate the clinical significance of fatigue in breast cancer patients before and during adjuvant chemotherapy treatment. Results also suggest that aggressive management of common side effects, such as nausea and pain, may be useful in relieving chemotherapy-related fatigue.
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                Author and article information

                Contributors
                Debra Lyon: delyon@ufl.edu
                Debra Kelly: dlynchkelly@ufl.edu
                Jeanne Walter: jmwalter@vcu.edu
                Harry Bear: hdbear@vcu.edu
                Leroy Thacker: s2lrthac@vcu.edu
                Ronald K Elswick: rkwlelswic@vcu.edu
                Journal
                Journal ID (nlm-ta): Springerplus
                Journal ID (iso-abbrev): Springerplus
                Title: SpringerPlus
                Publisher: Springer International Publishing (Cham )
                ISSN (Electronic): 2193-1801
                Publication date (Electronic): 23 July 2015
                Publication date PMC-release: 23 July 2015
                Publication date Collection: 2015
                Volume: 4
                Electronic Location Identifier: 369
                Affiliations
                [ ]Kirbo Endowed Chair, University of Florida College of Nursing, Gainesville, FL 32601 USA
                [ ]Virginia Commonwealth University School of Nursing, Richmond, Virginia USA
                [ ]Massey Cancer Center, School of Medicine, Virginia Commonwealth University, Richmond, Virginia USA
                Article
                Publisher ID: 1151
                DOI: 10.1186/s40064-015-1151-z
                PMC ID: 4584261
                PubMed ID: 26435889
                SO-VID: 074b8b96-2985-42b3-9bfa-c25a488c7ee8
                Copyright © © Lyon et al. 2015
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Date received : 6 April 2015
                Date accepted : 9 July 2015
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2015

                ScienceOpen disciplines: Uncategorized
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                ScienceOpen disciplines: Uncategorized

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