Transcranial Direct Current Stimulation for Cancer-related Cognitive Impairment in Breast Cancer Survivors

NCT ID: NCT07083518

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-29
• Study Completion Date: 2027-12-31

Brief Summary

This study aims to evaluate the efficacy of transcranial direct current stimulation (tDCS) in improving cancer-related cognitive impairment (CRCI) in breast cancer survivors. Participants will be randomly assigned to receive active or sham stimulation over the prefrontal cortex. Cognitive outcomes will be assessed using standardized neuropsychological tests and self-reported measures. Functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) will be used to explore neural correlates of intervention effects.

Detailed Description

This study is designed to evaluate the therapeutic effects of transcranial direct current stimulation (tDCS) on cancer-related cognitive impairment (CRCI) in breast cancer survivors. CRCI is a common and persistent complication among patients treated with systemic cancer therapies and has a substantial impact on quality of life, even after completion of treatment. Participants will be female breast cancer survivors who have completed primary treatments and report cognitive complaints. Eligible individuals will be randomized in a 1:1 ratio to receive either active or sham tDCS. The stimulation will be applied over the left dorsolateral prefrontal cortex (DLPFC), a brain region involved in executive function, memory, and attention. Each participant will receive multiple sessions of tDCS across a defined intervention period. The primary outcome will be the change in perceived cognitive function, measured by the total score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire. Secondary outcomes will include objective performance on neuropsychological tests (Trail Making Test, Auditory Verbal Learning Test, Digit Span Test), as well as patient-reported fatigue (Piper Fatigue Scale) and emotional symptoms (HAMD, HAMA). Neuroimaging (fMRI) and electrophysiological (EEG) data will also be collected in a subset of participants to explore neural correlates of treatment effects.

Conditions

Transcranial Direct Current Stimulation (tDCS); Breast Cancer Survivor; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Anodal tDCS

Participants will receive active tDCS for 20 minutes daily, 5 sessions per week, over 4 consecutive weeks (total 20 sessions). The anodal electrode was placed on the DLPFC (F3) surrounded by four cathodes with 1-cm diameter (FCz, AFz, F7, and C5). The stimulation direct current magnitude was set at 2 mA with a 30-s immediate decline at the beginning and end of each phase.

Group Type: ACTIVE_COMPARATOR

Anodal transcranial direct current stimulation

Intervention Type: DEVICE

tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, direct current applied directly to the head through scalp electrodes.

sham stimulation

Participants will receive sham stimulation for 20 minutes daily, 5 sessions per week, over 4 consecutive weeks (total 20 sessions). In the sham condition, a 30-s rising current until 2 mA is reached, with a 30-s decline immediately at the beginning and end of the stimulation section.

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

Sham tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Interventions

Anodal transcranial direct current stimulation

tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, direct current applied directly to the head through scalp electrodes.

Intervention Type: DEVICE

Sham transcranial direct current stimulation

Sham tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female breast cancer survivors aged 18-65 years.

2. Initially diagnosed with stage I-III non-metastatic breast cancer.

3. Between 6 months and 5 years after completion of initial curative surgery +/- radiation/chemotherapy.

4. allowed to be on endocrine therapy and/or anti-HER2 targeted therapy.

5. Self-reported cognitive complaints following cancer treatment.

6. Right-handedness (for standardized tDCS targeting)

7. Education level ≥ 6 years

8. Able and willing to undergo all study procedures (neuropsychological testing, MRI, EEG, etc.) and to provide written informed consent

Exclusion Criteria

1. Contraindications to MRI or EEG (e.g., pacemaker, metallic implants, claustrophobia).

2. Active neurological/psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia, Parkinson's disease, post-stroke sequelae)

3. Concurrent use of cognition-enhancing medications (e.g., donepezil, memantine)

4. Severe somatic diseases (cardiac/hepatic/renal insufficiency)

5. Pregnant or breastfeeding

6. Concurrent participation in another interventional clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

AHMU-tDCS-BC

Identifier Type: -

Identifier Source: org_study_id