Status:
COMPLETED
Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Robert L. Sloan Fund for Cancer Research
Conditions:
Breast Cancer
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
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. Tra...
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 br...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03487601
Start Date
December 12 2017
End Date
February 16 2019
Last Update
January 15 2021
Active Locations (2)
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1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410