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

NCT ID: NCT03143894

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2020-06-24

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer; Cognitive Dysfunction; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active tDCS first

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

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS

Intervention Type: OTHER

Sham Transcranial direct current stimulation (tDCS)..

Sham tDCS first

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.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS

Intervention Type: OTHER

Sham Transcranial direct current stimulation (tDCS)..

Interventions

tDCS

Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Intervention Type: DEVICE

Sham tDCS

Sham Transcranial direct current stimulation (tDCS)..

Intervention Type: OTHER

Other Intervention Names

Transcranial Direct Current Stimulation; NeuroConn DC Stimulator Plus Model 0021

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Under Armour, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy D Vannorsdall, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

J16135

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00110211

Identifier Type: -

Identifier Source: org_study_id