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

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ClinicalTrials.gov Identifier: NCT03143894
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Under Armour, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cognitive Dysfunction Fatigue Device: TDCS Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, sham-controlled, double-blind, cross-over
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active TDCS
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days
Device: TDCS
Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Other Names:
  • Transcranial Direct Current Stimulation
  • NeuroConn DC Stimulator Plus Model 0021

Sham Comparator: Sham TDCS
Stimulation mimicking the TDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days
Device: TDCS
Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Other Names:
  • Transcranial Direct Current Stimulation
  • NeuroConn DC Stimulator Plus Model 0021




Primary Outcome Measures :
  1. Change on Paced Auditory Serial Attention Test [ Time Frame: 6 weeks ]
    Change in auditory working memory


Secondary Outcome Measures :
  1. Change on Functional Assessment of Cancer Therapy Cognitive Scale [ Time Frame: 7 weeks ]
    Change in subjective cognitive functioning

  2. Change in Multidimensional Fatigue Symptom Inventory- SF [ Time Frame: 7 weeks ]
    Change in subjective fatigue


Other Outcome Measures:
  1. Brief cognitive battery [ Time Frame: 6 weeks ]
    Change in performance on a brief battery of cognitive tests



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-reported gender
Accepts Healthy Volunteers:   Yes
Criteria

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 of active breast cancer therapy, including surgery, radiation therapy and (neo)adjuvant chemotherapy, if administered. NOTE: Adjuvant HER2-targeted therapy and endocrine therapy 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 of the 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 literacy to complete study forms and questionnaires.
  • Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

  • Evidence of recurrent breast cancer at the time of enrollment.
  • Depression or anxiety as defined either by ongoing pharmacological treatment for depression 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 a physician, 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 or untreated hypothyroidism.
  • Use of stimulant medications, sleep medications, nicotine patch, and other drugs thought to interfere with tDCS efficacy for seven days prior to and during study participation.
  • Use of narcotic pain medication, benzodiazepines, or illicit drugs for seven days prior 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 proper application 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 might compromise the objectives of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143894


Contacts
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Contact: Mallory Blackwood, M.Sc. 410-502-6345 MBlack23@jhmi.edu

Locations
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United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Mallory Blackwood, MSc    410-502-6345    MBlack23@jhmi.edu   
Principal Investigator: Tracy D Vannorsdall, PhD         
Sub-Investigator: Karen Smith, MD, MPH         
Sub-Investigator: Antonio Wolff, MD         
Sub-Investigator: Chiung-Yu Huang, PhD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mallory Blackwood, MSc    410-502-6345    MBlack23@jhmi.edu   
Principal Investigator: Tracy D Vannorsdall, PhD         
Sub-Investigator: Karen Smith, MD, MPH         
Sub-Investigator: Antonio Wolff, MD         
Sub-Investigator: Chiung-Yu Huang, PhD         
Johns Hopkins Greenspring Station Recruiting
Lutherville, Maryland, United States, 21093
Contact: Mallory Blackwood, MSc    410-502-6345    MBlack23@jhmi.edu   
Principal Investigator: Tracy Vannorsdall, PhD         
Sub-Investigator: Karen Smith, MD, MPH         
Sub-Investigator: Antonio Wolff, MD         
Sub-Investigator: Chiung-Yu Huang, PhD         
Sponsors and Collaborators
Johns Hopkins University
Under Armour, Inc.
Investigators
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Principal Investigator: Tracy D Vannorsdall, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03143894     History of Changes
Other Study ID Numbers: IRB00110211
J16135 ( Other Identifier: Johns Hopkins University )
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
Breast Cancer
Cognition
Fatigue
Cancer-related Cognitive Impairment
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Breast Neoplasms
Fatigue
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Signs and Symptoms