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

Johns Hopkins University

Status: Terminated

Conditions: Breast Cancer; Cognitive Dysfunction; Fatigue

Treatments: Device: tDCS; Other: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03143894

J16135 (Other Identifier)

IRB00110211

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

7 participants in 2 patient groups

Active tDCS first

Active Comparator group

Description:

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.

Treatment:

Other: Sham tDCS

Device: tDCS

Sham tDCS first

Sham Comparator group

Description:

Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.

Treatment:

Other: Sham tDCS

Device: tDCS