Clinical trial NCT03143894: Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
Official title: Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Cognitive Dysfunction
Fatigue
Keywords: Breast Cancer
Cognition
Fatigue
Cancer-related Cognitive Impairment
Transcranial Direct Current Stimulation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Under Armour, Inc.
First posted: 2017-05-08
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, sham-controlled, double-blind, cross-over
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change on Paced Auditory Serial Attention Test (PASAT)
timeFrame: Baseline and Day 5
Secondary outcomes:
measure: Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
timeFrame: Baseline and Day 5
measure: Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)
timeFrame: Baseline and Day 5
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins Greenspring Station
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tracy D Vannorsdall, PhD
role: PRINCIPAL_INVESTIGATOR
References: