Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Psychology

Treatments: Device: low-frequency repetitive transcranial magnetic stimulation; Device: sham low-frequency repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05881889

8220053738

Details and patient eligibility

About

Introduction: Previous studies have shown that many breast cancer patients are suffering from fear of cancer recurrence (FCR). However, effective physical intervention for FCR has been scarce. In this study, low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral prefrontal cortex (DLPFC) will be applied on patients with high FCR. We aim to assess the efficacy of low-frequency rTMS in the treatment of FCR in breast cancer patients.

Methods and analysis: This will be a two-arm, randomised controlled trial comparing rTMS, sham stimulation in breast cancer patients with high FCR. A total of 50 breast cancer patients with a high FCR score (>27) will be recruited. Patients will be randomly assigned to receive 4-week rTMS, sham stimulation. Assessments will be conducted at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). The primary outcome of the study will be to ascertain, whether the rTMS program is sufficient in relieving FCR in breast cancer patients (measured by the 7-item FCR scale). Additionally, GAD7, PHQ9, NRS, and ISI7 will be used to measure individual's anxiety, depression, pain, and insomnia symptoms.

Full description

This study will be a parallel assignment randomised controlled trial (RCT). Patients will be randomly assigned to rTMS intervention group (rTMS+ TAU), sham stimulation group (sham+ TAU). Treatment will be performed 5 times a week for 4 weeks. Assessments will be conducted at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). The screening, assessments, allocation and intervention will all be carried out via a WeChat mini Program (a widely used social communication application, with more than 1.2 billion users in China) specially tailored for the trial. An information sheet will be provided online, and informed consent will be completed online before participation in the study.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult;
2. Breast cancer patients undergoing treatment for the first time;
3. Able to understand and sign informed consent;
4. Being able to comply with the intervention.

Exclusion criteria

1. Minors;
2. Having a diagnosis for a significant untreated mental or medical illness (e.g., consciousness disturbances, mania, acute phase of schizophrenia, major depressive disorder, etc.);
3. Patients with recurrent cancer;
4. Hospice patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

repetitive transcranial magnetic stimulation

Experimental group

Description:

For patients in the rTMS group, we will first determine the intensity of the rTMS protocol by assessing the individual resting motor threshold (rMT). After determination of each individual's rMT, we will set rTMS intensity at 100% of the rMT and apply a single train of low-frequency rTMS over the DLPFS at 1 Hz for a total duration of 30 min (2000 pulses). receive 4 week rTMS treatment.

Treatment:

Device: low-frequency repetitive transcranial magnetic stimulation

sham stimulation

Sham Comparator group

Description:

For patients in the sham group, we will apply rTMS over the DLPFS in sham modality.

Treatment:

Device: sham low-frequency repetitive transcranial magnetic stimulation