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

NCT03143894 | Terminated Results DMC FDA Device

• 2 other identifiers: IRB00110211J16135
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Cognitive Dysfunction; Fatigue

Keywords

Breast Cancer; Cognition; Fatigue; Cancer-related Cognitive Impairment; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Change on Paced Auditory Serial Attention Test (PASAT)

  Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.

  Baseline and Day 5

Secondary Outcomes (2)

• Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)

  Baseline and Day 5

• Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)

  Baseline and Day 5

Study Arms (2)

Active tDCS first

ACTIVE COMPARATOR

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

Device: tDCS; Other: Sham tDCS

Sham tDCS first

SHAM COMPARATOR

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.

Device: tDCS; Other: Sham tDCS

Interventions

tDCS 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.

Also known as: Transcranial Direct Current Stimulation, NeuroConn DC Stimulator Plus Model 0021

Active tDCS first; Sham tDCS first

Sham tDCS OTHER

Sham Transcranial direct current stimulation (tDCS)..

Active tDCS first; Sham tDCS first

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-reported gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Under Armour, Inc.: collaborator

Study Sites (3)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Greenspring Station

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction; Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Tracy Vannorsdall, PhD
• Organization: Johns Hopkins University

TVannor1@jhmi.edu

410-502-3701

Study Officials

• Tracy D Vannorsdall, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, sham-controlled, double-blind, cross-over

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: April 21, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: May 12, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)