Clinical trial · Interventional
Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psychology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-frequency repetitive transcranial magnetic stimulation | Device | — | UNRESOLVED |
| sham low-frequency repetitive transcranial magnetic stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- repetitive transcranial magnetic stimulation
- 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.
- interventionNames
- Device: low-frequency repetitive transcranial magnetic stimulation
- type
- SHAM_COMPARATOR
- label
- sham stimulation
- description
- For patients in the sham group, we will apply rTMS over the DLPFS in sham modality.
- interventionNames
- Device: sham low-frequency repetitive transcranial magnetic stimulation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDXu W, Zhao N, Li W, Qiu L, Luo X, Lin Y, Wang W, Garg S, Sun H, Yang Y. Effects of repetitive transcranial magnetic stimulation on fear of cancer recurrence and its underlying neuromechanism. Contemp Clin Trials Commun. 2024 Apr 23;39:101299. doi: 10.1016/j.conctc.2024.101299. eCollection 2024 Jun. PMID 38720913