Evidence map›Paper›PMID 26435889›Full record

ArticleSpringerPlus2015

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.

Debra Lyon, Debra Kelly, Jeanne Walter, Harry Bear, Leroy Thacker, Ronald K Elswick

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in SpringerPlus, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00902330 (Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00902330 phase3completednot on this map

Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

TypeinterventionalSponsorVirginia Commonwealth UniversityRan2009 to 2014Enrolled161ConditionsAnxiety Disorder, Breast Cancer, Depression, FatigueArmsenergy-based therapy, sham intervention
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Observational
  11. Article
  12. Low-Intensity Transcranial Current Stimulation in Psychiatry.The American journal of psychiatry · 2017
    Review
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Debra LyonKirbo Endowed Chair, University of Florida College of Nursing, Gainesville, FL 32601 USA.
Debra KellyKirbo Endowed Chair, University of Florida College of Nursing, Gainesville, FL 32601 USA.
Jeanne WalterVirginia Commonwealth University School of Nursing, Richmond, Virginia USA.
Harry BearMassey Cancer Center, School of Medicine, Virginia Commonwealth University, Richmond, Virginia USA.
Leroy ThackerVirginia Commonwealth University School of Nursing, Richmond, Virginia USA.
Ronald K ElswickVirginia Commonwealth University School of Nursing, Richmond, Virginia USA.
Virginia Commonwealth University · USFlorida College · US

Funding

Cranial Stimulation for Chemotherapy Symptoms in Breast CancerR01CA127446 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI MCGUIRE, DEBORAH B. · 2009 to 2013
$1.5M
NCI NIH HHS R01 CA127446
6 · The paper itself

Abstract

purposeWomen 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.

methodsThis 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.

resultsThe 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.

conclusionIn 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.

Identifiers

PMID26435889
PMCPMC4584261
OpenAlexW1927730408

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.