NCT04563013

Brief Summary

Patients diagnosed with breast cancer who received assisted radiotherapy were recruited and the transcutaneous auricular vagus nerve stimulation (taVNS) was applied. The aim of of study is : 1) to study whether taVNS could improve the patient's fatigue, quality of life under radiotherapy or chemotherapy; 2) to investigate the effects of taVNS on the levels of patients' lymphocyte subsets and proinflammatory cytokines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

September 14, 2020

Last Update Submit

March 14, 2024

Conditions

Breast CancerCancer, Therapy-RelatedCancer-related FatigueQuality of Life

Keywords

Cancer-related fatigueTranscutaneous vagus nerve stimulationBreast cancerRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • the score of fatigue at 1 month

    For fatigue degree evaluation, the Brief Fatigue Inventory (BFI) was used. The score of fatigue in two groups will be evaluated by BFI and will be compared. The scale uses the 11-point scoring method, whereby 0 points indicates no fatigue and 10 points the most severe fatigue. A higher score indicates more severe fatigue. The BFI included three fatigue severity items and six fatigue interference items. Three fatigue severity items ask patients to rate the severity of their fatigue at its "worst", "usual" and "now" during the past 24 h and another six fatigue interference items describe how much fatigue has interfered with different aspects of the patient's life during past 24 h, including general activity, mood, walking ability, normal work, relationships with other people and enjoy of life.

    The taVNS treatment lasted about five weeks, data were collected at 1 month after the end of the taVNS treatment

Secondary Outcomes (6)

  • the scores of HADS at End and at 1 month

    The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment

  • the scores of PSQI at End and at 1 month

    The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment

  • the scores of EORTC QLQ-C30 at End and at 1 month

    The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment

  • the change of cell counts of blood cells from baseline to End and to 1M.

    The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment

  • the change in IL-6 level from baseline to End and to 1M.

    The taVNS treatment lasted about five weeks, data were collected at the end of RT and taVNS treatment and 1 month after the end of taVNS treatment

  • +1 more secondary outcomes

Study Arms (2)

Sham taVNS

SHAM COMPARATOR

The participants under conventional radiotherapy were applied with sham taVNS at the left tragus with the power off for 30min. The intervention would last until to the end of conventional radiotherapy.

Device: Transcutaneous vagus nerve stimulation

taVNS

ACTIVE COMPARATOR

For taVNS group, the electrodes were attached to the tragus of left ear after skin preparation with an alcohol pad. The stimulation current was a single-phase rectangular pulse with the following stimulation parameters: duty circle: 60 s "on" periods and 10 s "off" periods; frequency: 30 Hz; pulse width: 200 μs; pulse amplitude of 0.5 mA to 1.5 mA; stimulation time:30 min.

Device: Transcutaneous vagus nerve stimulation

Interventions

Transcutaneous vagus nerve stimulationDEVICE

the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.

Sham taVNStaVNS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants diagnosed with breast cancer, suitable for adjuvant radiotherapy after surgery;
  • Eastern Cooperative Oncology Group (ECOG) physical condition score: 0\~1 point.

You may not qualify if:

  • Participants with organic brain lesions (cerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy, etc.);
  • Participants with peptic ulcer, arrhythmia, or cardiac corrected QT interval\> 450ms;
  • Participants who have slow breathing (less than 10 breaths per minute);
  • Participants who are or have been diagnosed with other major diseases (coronary heart disease, pulmonary heart disease, etc.);
  • Participants who are currently or have been diagnosed with mental disorders other than major depressive disorder;
  • Participants who are or have participated in vagus nerve or transcranial electrical stimulation treatment for less than 3 months;
  • Participants who are not suitable for vagus nerve stimulation treatment;
  • Participants who refuse to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xidian University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Li-Na Zhao, Doctor

    the First Affiliated Hospital of the Air Force Medical University

    PRINCIPAL INVESTIGATOR

  • Wei Qin, Doctor

    Xidian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 24, 2020

Study Start

September 23, 2020

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

the data will be available by the publication of articles

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The information will be available by the publication of articles

Locations

CN(1)