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

NCT05881889 | Unknown

• 1 other identifier: 8220053738
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychology

Outcome Measures

Primary Outcomes (1)

• Fear of Cancer Recurrence Questionnaire (FCRQ7)

  There are 7 items scored on 5 levels, the total score of each item is summed up. The score above 27 indicates that the patient has significant fear, which requires certain psychological intervention and treatment.

  we use FCRQ7 to assess the change of FCR level from baseline to 4, 5, 8, 16 weeks follow up

Secondary Outcomes (4)

• Patient Health Questionnaire (PHQ9)

  we use PHQ9 to assess the change of depression level from baseline to 4, 5, 8, 16 weeks follow up

• Generalized Anxiety Disorder (GAD7)

  we use GAD7 to assess the change of anxiety level from baseline to 4, 5, 8, 16 weeks follow up

• Numeric Rating Scale (NRS)

  we use NRS to assess the change of pain level from baseline to 4, 5, 8, 16 weeks follow up

• Insomnia Severity Index (ISI)

  we use ISI to assess the change of insomnia severity from baseline to 4, 5, 8, 16 weeks follow up

Study Arms (2)

repetitive transcranial magnetic stimulation

EXPERIMENTAL

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.

Device: low-frequency repetitive transcranial magnetic stimulation

sham stimulation

SHAM COMPARATOR

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

Device: sham low-frequency repetitive transcranial magnetic stimulation

Interventions

low-frequency repetitive transcranial magnetic stimulation 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).

repetitive transcranial magnetic stimulation

sham low-frequency repetitive transcranial magnetic stimulation DEVICE

sham low-frequency repetitive transcranial magnetic stimulation

sham stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Related Publications (1)

• 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.

  PMID: 38720913 DERIVED

Central Study Contacts

Yuan Yang, Doctor

CONTACT

18825059293; yangyuan@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 31, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2025
• Last Updated: May 31, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share