Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03143894
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03143894
Study Brief:
Protocol Section:
NCT03143894