Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation

Last updated: April 19, 2021
Sponsor: Johns Hopkins University
Overall Status: Terminated

Phase

N/A

Condition

Memory Loss

Pain (Pediatric)

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT03143894
IRB00110211
J16135
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women, 18 years of age or older
  • Stage I-III breast cancer
  • Treatment Status: At least 6 months and no more than 5 years after the conclusion ofactive breast cancer therapy, including surgery, radiation therapy and (neo)adjuvantchemotherapy, if administered. NOTE: Adjuvant HER2-targeted therapy and endocrinetherapy may still be ongoing at the time of study enrollment.
  • Fatigue: Moderate fatigue on most days within the past week (i.e., at least 4 out ofthe last 7 days), rated as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue) scale.
  • Able and willing to complete study tasks as evidenced by at least the following:fluent English speaker; hearing and language comprehension; and, sufficient literacyto complete study forms and questionnaires.
  • Patient understands the study regimen, its requirements, risks, and discomforts, andis able and willing to sign an informed consent form.

Exclusion

Exclusion Criteria:

  • Evidence of recurrent breast cancer at the time of enrollment.
  • Depression or anxiety as defined either by ongoing pharmacological treatment fordepression or anxiety or a HADS score on initial screening.
  • Dementia as assessed by a MMSE score on initial screening.
  • Known pregnancy or nursing.
  • Any of the following: diagnosis of schizophrenia or bipolar disorder made by aphysician, seizure disorder, pacemaker, hearing aids, any metal implanted in the head,or the presence of other known current untreated causes of fatigue such as anemia oruntreated hypothyroidism.
  • Use of stimulant medications, sleep medications, nicotine patch, and other drugsthought to interfere with tDCS efficacy for seven days prior to and during studyparticipation.
  • Use of narcotic pain medication, benzodiazepines, or illicit drugs for seven daysprior to and during study participation.
  • Consumption of >14 alcoholic drinks per week or positive screening on the CAGE.
  • Skin conditions involving open sores on the scalp that would prevent properapplication of the electrodes.
  • Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks,braids or other hair accessories that cannot be removed.
  • Other medical or other condition(s) that in the opinion of the investigators mightcompromise the objectives of the study.

Study Design

Total Participants: 7
Study Start date:
April 21, 2017
Estimated Completion Date:
June 24, 2020

Study Description

Fatigue and cognitive dysfunction are commonly reported symptoms associated with impaired quality of life and productivity in breast cancer survivors. Transcranial direct current stimulation (tDCS) has been shown to improve both fatigue and cognition. Here tDCS will be used in a randomized, sham-controlled, double-blind, cross-over trial in women who have finished treatment of breast cancer and who report persistent fatigue.

Participants will complete measures of fatigue and cognition before and after five consecutive days of active or sham tDCS then complete questionnaires by phone one week later. Participants will return about one month later for another five days of participation, followed by another brief study phone call the following week.

Connect with a study center

  • Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Sibley Memorial Hospital

    Washington, D.C., District of Columbia 20016
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Greenspring Station

    Lutherville, Maryland 21093
    United States

    Site Not Available

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