Clinical trial NCT03487601: Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function
Official title: Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function During Breast Cancer Chemotherapy: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fatigue
Keywords: docetaxel
Stage I - IV
chemotherapy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Robert L. Sloan Fund for Cancer Research
First posted: 2018-04-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Fatigue and cognitive impairment are commonly reported symptoms associated with impaired quality of life (QOL) and productivity in breast cancer patients receiving chemotherapy. Working memory, the brain's system for temporarily storing and manipulating information required to carry out more complex cognitive tasks, is particularly affected by cancer and its treatment.

In women who have undergone chemotherapy for breast cancer, neuroimaging studies show structural brain changes as well as functional inefficiencies in a region critical for working memory, the left dorsolateral prefrontal cortex (DLPFC). Fatigue appears to play a critical role in the recruitment of the DLPFC during cognitive tasks.

Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form of electrical brain stimulation that enhances neuronal transmission beneath scalp electrodes. Our group and others have shown that when applied to the left DLPFC, tDCS improves energy in patients with fatiguing medical conditions and that it improves cognition in both healthy adults and those with neurodegenerative diseases.

The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment. Eligible individuals will be ≥ age 18 years with stage I-IV breast cancer undergoing docetaxel-based chemotherapy every 3 weeks (at least 60 mg/m2 dose) with or without HER2-targeted therapy who self-report moderate or severe fatigue (rated ≥ 4 on a scale of 0-10) during at least 3 days of their most recent chemotherapy cycle. 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.

Participants will complete self-report measures of fatigue, cognitive function and QOL along with cognitive testing at the beginning and end of the five-day intervention. Subjective fatigue, QOL and cognitive function will be also assessed prior to administration of the next cycle of chemotherapy. Total time on study will be approximately 3 weeks (one cycle of chemotherapy). Daily subjective fatigue will be monitored throughout participation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

  • Note: presence of a mediport is not an exclusion criteria
* 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
* Use of illicit drugs for seven days prior to and during study participation.
* Self-reported consumption of \> 14 alcoholic drinks per week or positive screening on the CAGE questionnaire in relation to the past year. NOTE: A single, standard alcoholic drink is defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine or 30 mL of liquor.
* 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.
* Known history of brain metastases or leptomeningeal carcinomatosis (even if adequately treated)
* Prior brain surgery
* Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study

Primary outcomes:
measure: Feasibility of tDCS
timeFrame: Day 5
Secondary outcomes:
measure: Fatigue
timeFrame: Day 1, Day 5, and at End of study (approximately 3 weeks)
measure: Subjective Cognitive Function
timeFrame: Day 1, Day 5, and at end of study (approximately 3 weeks)
measure: Objective Cognitive Function
timeFrame: Day 1 and Day 5
measure: Quality of Life
timeFrame: Day 1, Day 5, End of study (approximately 3 weeks)
Other outcomes:
measure: Daily Fatigue
timeFrame: Daily from Day 1 to End of study (approximately 3 weeks)
measure: Patient-Reported Side effects of tDCS
timeFrame: Before and after study intervention on Days 1, 2, 3, 4, 5
measure: Cognitive Function other than working memory (TMT)
timeFrame: Before and after study intervention on Days 1-5
measure: Cognitive Function other than working memory (CIFA)
timeFrame: Before and after study intervention on Days 1-5
measure: Chemotherapy administration
timeFrame: End of study (approximately 3 weeks)
measure: Medical Record Review
timeFrame: Baseline and End of study (approximately 3 weeks)
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Karen Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: