Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03143894 : Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03143894      |      Link to official Clinicaltrials.gov listing
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