Breast CancerNCT03143894
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
A study testing tDCS in people with Breast Cancer and Cognitive Dysfunction, run by Johns Hopkins University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cognitive Dysfunction, Fatigue
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2017to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Johns Hopkins Greenspring Station
Lutherville, Maryland, 21093
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Cognitive Dysfunction, Fatigue
- Being tested
- tDCS, Sham tDCS
- Keywords
- Breast Cancer, Cognition, Fatigue, Cancer-related Cognitive Impairment, Transcranial Direct Current Stimulation
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Transcranial Direct Current Stimulation, NeuroConn DC Stimulator Plus Model 0021
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.
Sham tDCSOther
Sham Transcranial direct current stimulation (tDCS)..
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS first | Active comparator | 2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout. Receives: Device: tDCS; Other: Sham tDCS |
| Sham tDCS first | Sham comparator | 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. Receives: Device: tDCS; Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 5
Secondary outcomes (2)
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.
Measured: Baseline and Day 5
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.
Measured: Baseline and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start21 Apr 2017
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Why it stopped: Poor accrual (inability to enroll participants)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, sham-controlled, double-blind, cross-over
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Under Armour, Inc.
- Responsible party
- Sponsor
- Investigators
- Tracy D Vannorsdall, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143894
- Sponsor's protocol ID
- IRB00110211
- Other IDs
- J16135
- Status last verified
- Apr 2021
- First submitted
- 4 May 2017
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT03143894
- Acronym / sponsor ID
- IRB00110211
- Conditions
- Breast Cancer, Cognitive Dysfunction, Fatigue
- Keywords
- Breast Cancer, Cognition, Fatigue, Cancer-related Cognitive Impairment, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual (inability to enroll participants)
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Under Armour, Inc.
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Posted 12 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, sham-controlled, double-blind, cross-over
| Arm | Type | Receives |
|---|---|---|
| Active tDCS first | Active comparator | Device: tDCS, Other: Sham tDCS2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout. |
| Sham tDCS first | Sham comparator | Device: tDCS, Other: Sham tDCSStimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: Transcranial Direct Current Stimulation, NeuroConn DC Stimulator Plus Model 0021Transcranial 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. | Device | Active tDCS first, Sham tDCS first |
| Sham tDCSSham Transcranial direct current stimulation (tDCS).. | Other | Active tDCS first, Sham tDCS first |
Primary outcome
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.
2 secondary outcomes
Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
Time frame: Baseline and Day 5
Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)
Time frame: Baseline and Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy D Vannorsdall, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Breast Cancer and Cognitive Dysfunction, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Paced Auditory Serial Attention Test (PASAT) (time frame: Baseline and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.