Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03487601 : Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03487601      |      Link to official Clinicaltrials.gov listing
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