[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|
|Ages||Min: 18 Years Max: N/A|
- 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.
- 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
- 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
- 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03143894
| Link to official Clinicaltrials.gov listing