gastrointestinal cancers
Conditions
Interventions
Sham stimulation control group:Receive sham stimulation in addition to routine intervention.
Sponsors
Jing'an District Central Hospital Of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years; 2. Patients pathologically or cytologically diagnosed with gastrointestinal cancers (gastric cancer or colorectal cancer), aware of their diagnosis, with TNM stage I–IV; 3. Have not received any anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, and immunotherapy) within 2 weeks prior to assessment and during the intervention period, with expected survival >3 months; 4.Admitted primarily for symptomatic supportive care (including analgesia, nutritional support, anti-infection treatment, etc.), with the treatment regimen remaining unchanged during the study period; 5.Positive screening for fatigue symptoms (NRS >3); 6. Karnofsky Performance Status (KPS) score >40; 7. Conscious, without cognitive or language impairment, able to complete questionnaires and assessments; 8. The patient or their family member has signed the informed consent form and voluntarily agrees to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Presence of relevant cardiac diseases (e.g., bradyarrhythmia, cardiac insufficiency, post-myocardial infarction status); 2.Presence of severe mental illness, physical disease, or organ dysfunction; 3. Currently receiving vagus nerve stimulation, having a history of vagotomy, or participating in other studies; 4.Presence of active implanted devices (e.g., implantable cardioverter-defibrillator, cardiac pacemaker, neurostimulator, cochlear implant, ventriculoperitoneal shunt); 5.Presence of skin diseases (e.g., infection or eczema) or anatomical abnormalities at the stimulation site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Assessment of Chronic Illness Therapy-Fatigue,FACIT-F; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiorespiratory endurance;Changes in HbO2 and HbR concentrations;Cancer Fatigue Scale,CFS;Biomarker;? band, a1 band, a2 band, and ß band.;Grip;Heart rate variability;The 30-second chair stand test;Body dimensions;IPAQ-SF;Multidimensional Fatigue Inventory-20, MFI-20;Pittsburgh Sleep Quality Index, PSQI;Hospital Anxiety and Depression Scale, HADS;Nutritional Risk Screening 2002, NRS 2002;Numeric Rating Scale for Fatigue;Gastrointestinal Symptom Rating Scale,GSRS;EORTC QLQ-C30;Karnofsky Performance Status Score; | — |
Countries
China
Contacts
Public ContactJia Jie
Huashan Hospital, Fudan University
Outcome results
None listed