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Title:
Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function During Breast Cancer Chemotherapy: A Feasibility Study
Protocol Number:
J17138
Phase:
Pilot
Physician:
Karen Smith
Sites:
Sibley Memorial Hospital
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Fatigue and cognitive impairment are commonly reported symptoms associated with impaired quality of life (QOL) and productivity in breast cancer patients receiving chemotherapy. Working memory, the brain’s system for temporarily storing and manipulating information required to carry out more complex cognitive tasks, is particularly affected by cancer and its treatment. In women who have undergone chemotherapy for breast cancer, neuroimaging studies show structural brain changes as well as functional inefficiencies in a region critical for working memory, the left dorsolateral prefrontal cortex (DLPFC). Fatigue appears to play a critical role in the recruitment of the DLPFC during cognitive tasks. Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form of electrical brain stimulation that enhances neuronal transmission beneath scalp electrodes. Our group and others have shown that when applied to the left DLPFC, tDCS improves energy in patients with fatiguing medical conditions and that it improves cognition in both healthy adults and those with neurodegenerative diseases.
Eligibility:
Women or men, 18 years of age or older Stage I-IV breast cancer receiving docetaxel-based chemotherapy (at least 60 mg/m2) every 21 days•Docetaxel may be administered concurrently with other chemotherapy agents and/or with HER2 targeted therapies at the discretion of the treating provider Fatigue: Self-report of moderate or severe fatigue on at least 3 days during the prior cycle of docetaxel-based chemotherapy, defined as equal to 4 on a 0 (no fatigue) to 10 (worst fatigue imaginable) scale.Able and willing to complete study tasks as evidenced by at least the following according to the assessment of a study team member: fluent English speaker; hearing and language comprehension; and, sufficient literacy to complete study forms and questionnairesPatient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Treatment:
The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment. Eligible individuals will be equal to age 18 years with stage I-IV breast cancer undergoing docetaxel-based chemotherapy every 3 weeks (at least 60 mg/m2 dose) with or without HER2-targeted therapy who self-report moderate or severe fatigue (rated equal to 4 on a scale of 0-10) during at least 3 days of their most recent chemotherapy cycle. Participants will be randomized to either active or sham tDCS and will undergo 5 consecutive treatments of daily tDCS beginning the Monday following the first day of their on-study chemotherapy cycle. Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days. Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants. Participants will complete self-report measures of fatigue, cognitive function and QOL along with cognitive testing at the beginning and end of the five-day intervention. Subjective fatigue, QOL and cognitive function will be also assessed prior to administration of the next cycle of chemotherapy. Total time on study will be approximately 3 weeks (one cycle of chemotherapy). Daily subjective fatigue will be monitored throughout participation.For our primary endpoint, we will assess the feasibility of 5 consecutive days of tDCS during docetaxel-based chemotherapy. We will define tDCS to be feasible in this setting if greater than 80% of participants complete 4 of the 5 planned stimulation sessions. The secondary objectives will be comparisons of the mean differences in subjective fatigue, subjective cognitive function, QOL and objective cognitive function from baseline (prior to tDCS) to completion of tDCS between the active and sham arms. We expect fatigue, cognitive function and QOL to worsen or remain unchanged in the sham group and hypothesize that these parameters will improve or that worsening will be less extreme in the active group. Exploratory analyses will include measures of daily fatigue, change in additional measures of objective cognitive function with stimulation and persistence of changes in fatigue, cognitive function and QOL after stimulation. Safety of tDCS in this population will also be assessed as will any impact it has on subsequent timely administration of chemotherapy. We will also perform exploratory analyses to assess factors which are associated with favorable effects of tDCS on fatigue, QOL and cognition.
Population:
Adult
Last Update
12/09/2019 05:03 AM