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

Primary Purpose

Breast Cancer, Cognitive Dysfunction, Fatigue

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Cognition, Fatigue, Cancer-related Cognitive Impairment, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sibley Memorial Hospital
  • Johns Hopkins Hospital
  • Johns Hopkins Greenspring Station

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS first

Sham tDCS first

Arm Description

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.

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.

Outcomes

Primary Outcome Measures

Change on Paced Auditory Serial Attention Test (PASAT)
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

Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
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.
Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)
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.

Full Information

First Posted
May 4, 2017
Last Updated
April 19, 2021
Sponsor
Johns Hopkins University
Collaborators
Under Armour, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03143894
Brief Title
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
Official Title
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual (inability to enroll participants)
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Under Armour, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cognitive Dysfunction, Fatigue
Keywords
Breast Cancer, Cognition, Fatigue, Cancer-related Cognitive Impairment, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, sham-controlled, double-blind, cross-over
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS first
Arm Type
Active Comparator
Arm Description
2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.
Arm Title
Sham tDCS first
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
Transcranial Direct Current Stimulation, NeuroConn DC Stimulator Plus Model 0021
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham tDCS
Intervention Description
Sham Transcranial direct current stimulation (tDCS)..
Primary Outcome Measure Information:
Title
Change on Paced Auditory Serial Attention Test (PASAT)
Description
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.
Time Frame
Baseline and Day 5
Secondary Outcome Measure Information:
Title
Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
Description
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.
Time Frame
Baseline and Day 5
Title
Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)
Description
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.
Time Frame
Baseline and Day 5

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-reported gender
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy D Vannorsdall, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins Greenspring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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