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

NCT ID: NCT05881889

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-30

Brief Summary

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.

Detailed 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.

Conditions

Psychology

Study Design

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

Study Groups

repetitive transcranial magnetic stimulation

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.

Group Type: EXPERIMENTAL

low-frequency repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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).

sham stimulation

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

Group Type: SHAM_COMPARATOR

sham low-frequency repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

sham low-frequency repetitive transcranial magnetic stimulation

Interventions

low-frequency repetitive transcranial magnetic stimulation

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).

Intervention Type: DEVICE

sham low-frequency repetitive transcranial magnetic stimulation

sham low-frequency repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yuan Yang, Doctor

Role: CONTACT

yangyuan@gdph.org.cn

18825059293

References

Xu 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.

Reference Type: DERIVED

PMID: 38720913 (View on PubMed)

Other Identifiers

8220053738

Identifier Type: -

Identifier Source: org_study_id