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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 : Terminated (Poor accrual (inability to enroll participants))
First Posted : May 8, 2017
Results First Posted : May 12, 2021
Last Update Posted : May 12, 2021
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 Other: Sham 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)
Actual Enrollment : 7 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
Actual Primary Completion Date : June 24, 2020
Actual Study Completion Date : June 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active tDCS first
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.
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

Other: Sham tDCS
Sham Transcranial direct current stimulation (tDCS)..

Sham Comparator: Sham tDCS first
Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.
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

Other: Sham tDCS
Sham Transcranial direct current stimulation (tDCS)..




Primary Outcome Measures :
  1. Change on Paced Auditory Serial Attention Test (PASAT) [ Time Frame: Baseline and Day 5 ]
    Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.


Secondary Outcome Measures :
  1. Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) [ Time Frame: Baseline and Day 5 ]
    Change in subjective cognitive functioning as measured by the FACT-Cog Perceived Cognitive Impairment scale prior to and following the intervention. Raw scores range from 0 to 72, with higher scores reflecting better perceived cognitive functioning. Larger positive change scores reflect greater improvement in subjective cognitive functioning from baseline whereas greater negative change scores reflect declines in subjective cognitive functioning from baseline.

  2. Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF) [ Time Frame: Baseline and Day 5 ]
    Change in subjective fatigue as measured by the MFSI-SF prior to and following the intervention. Raw scores range from -36 to + 144, with higher scores reflecting greater levels of fatigue. Larger positive change scores reflect greater improvement in fatigue from baseline whereas greater negative change scores reflect declines in fatigue from baseline.



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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


Locations
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United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Johns Hopkins Greenspring Station
Lutherville, Maryland, United States, 21093
Sponsors and Collaborators
Johns Hopkins University
Under Armour, Inc.
Investigators
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Principal Investigator: Tracy D Vannorsdall, PhD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03143894    
Other Study ID Numbers: IRB00110211
J16135 ( Other Identifier: Johns Hopkins University )
First Posted: May 8, 2017    Key Record Dates
Results First Posted: May 12, 2021
Last Update Posted: May 12, 2021
Last Verified: April 2021
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
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 Neoplasms
Fatigue
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders