Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function
2 other identifiers
interventional
3
1 country
2
Brief Summary
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve fatigue and certain thinking skills in women with breast cancer receiving chemotherapy. Transcranial Direct Current Stimulation is a form of brain stimulation during which low amounts of electrical current are delivered to the brain using electrodes attached to the scalp. The idea of using electrical stimulation to affect neurological symptoms has been around for more than 100 years with the first reported use in 1801. Since the 1960s, tDCS has been used in research for a variety of reasons including stroke rehabilitation, memory enhancement and for depression. People aged 18 or older who are currently receiving chemotherapy with docetaxel and who are experiencing fatigue may join.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Dec 2017
Shorter than P25 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2017
CompletedFirst Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2019
CompletedJanuary 15, 2021
July 1, 2020
1.2 years
February 2, 2018
January 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of tDCS
Evaluation of the feasibility of 5 consecutive days of tDCS in breast cancer patients receiving docetaxel-based chemotherapy. Feasibility will be evaluated by assessing the proportion of study participants who complete at least 4 of 5 days of the planned tDCS intervention (active or sham) during docetaxel-based chemotherapy. If \>80% of participants complete 4 of the 5 planned stimulation sessions, tDCS will be defined as feasible.
Day 5
Secondary Outcomes (4)
Fatigue
Day 1, Day 5, and at End of study (approximately 3 weeks)
Subjective Cognitive Function
Day 1, Day 5, and at end of study (approximately 3 weeks)
Objective Cognitive Function
Day 1 and Day 5
Quality of Life
Day 1, Day 5, End of study (approximately 3 weeks)
Other Outcomes (6)
Daily Fatigue
Daily from Day 1 to End of study (approximately 3 weeks)
Patient-Reported Side effects of tDCS
Before and after study intervention on Days 1, 2, 3, 4, 5
Cognitive Function other than working memory (TMT)
Before and after study intervention on Days 1-5
- +3 more other outcomes
Study Arms (2)
Active tDCS
ACTIVE COMPARATORActive transcranial direct current stimulation: Participants will undergo five consecutive days (Monday-Friday) of active stimulation beginning the Monday after their on-study chemotherapy administration. Questionnaires and cognitive assessment will be completed on the first and last days of stimulation (i.e., Monday and Friday). On all 5 days, participants will engage in cognitive tasks while receiving stimulation (either active or sham) in order to maximize stimulation effects 43. In order to assess for duration of subjective effects, participants will complete self-report measures of subjective fatigue, cognitive function and QOL immediately prior to their next chemotherapy (approximately 10-14 days after completion of stimulation).
Sham tDCS
SHAM COMPARATORSham transcranial direct current stimulation: Participants will undergo five consecutive days (Monday-Friday) of sham stimulation beginning the Monday after their on-study chemotherapy administration. Questionnaires and cognitive assessment will be completed on the first and last days of stimulation (i.e., Monday and Friday). On all 5 days, participants will engage in cognitive tasks while receiving stimulation (either active or sham) in order to maximize stimulation effects 43. In order to assess for duration of subjective effects, participants will complete self-report measures of subjective fatigue, cognitive function and QOL immediately prior to their next chemotherapy (approximately 10-14 days after completion of stimulation).
Interventions
Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days.
Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants.
Eligibility Criteria
You may qualify if:
- Women or men, 18 years of age or older
- Stage I-IV breast cancer receiving docetaxel-based chemotherapy (at least 60 mg/m2) every 21 days
- Docetaxel may be administered concurrently with other chemotherapy agents and/or with HER2 targeted therapies at the discretion of the treating provider
- Fatigue: Self-report of moderate or severe fatigue on at least 3 days during the prior cycle of docetaxel-based chemotherapy, defined as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue imaginable) scale.
- Able and willing to complete study tasks as evidenced by at least the following according to the assessment of a study team member: 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.
You may not qualify if:
- Dementia as assessed by a MMSE score \< 24 on initial screening.
- Known pregnancy or nursing.
- Any of the following: known diagnosis of schizophrenia or bipolar disorder, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, untreated hypothyroidism, aphasia, delirium, known neurologic disorder which affects cognitive function, prior traumatic brain injury, known heart failure
- Use of the following medications for seven days prior to and during study participation:
- Stimulant medications
- Carbamazepine/Tegretol
- Cough/cold medicines (e.g. Dextromethorphan, Triaminic, Robitussin, Vics Formula 44)
- Flunarizine/Sibelium
- Propanolol/Inderal
- Sulpiride
- Pergolide
- Rivastigmine/Exelon
- Carbidopa/levodopa or levodopa
- Ropinirole/Requip
- Nicotine patch
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Smith, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be randomized to either active or sham tDCS and will undergo 5 consecutive treatments of daily tDCS beginning the Monday following the first day of their on-study chemotherapy cycle. Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days. Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2018
First Posted
April 4, 2018
Study Start
December 12, 2017
Primary Completion
February 16, 2019
Study Completion
February 16, 2019
Last Updated
January 15, 2021
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
For the feasibility endpoint, we will report the count, proportion, and 90% confidence interval of participants completing at least 4 tDCS sessions. The summary statistics will be reported by study arm and for all patients.