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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Breast Cancer, Cognitive Dysfunction, Fatigue

In brief

This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.

Key facts

Study ID

NCT03143894

Run by

Johns Hopkins University

People needed

7

Starts

2017-04-21

Expected to finish

2020-06-24

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Johns Hopkins Greenspring Station — Lutherville, Maryland, United States

Full record on ClinicalTrials.gov

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