Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.