Chemotherapy-induced Gastrointestinal Symptom Cluster, Electroacupuncture, Standard Quadruple Antiemetic Therapy
Conditions
Keywords
breast cancer, chemotherapy, standard quadruple antiemetic therapy, electroacupuncture, chemotherapy-induced gastrointestinal symptom cluster
Brief summary
This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify the key targets of electroacupuncture intervention, thereby providing high-level evidence-based medical support and theoretical foundations for optimizing electroacupuncture strategies in addressing chemotherapy-induced gastrointestinal symptoms in patients with cancer.
Detailed description
This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + dexamethasone + 5-HT3 receptor antagonist + NK-1 receptor antagonist) versus sham EA plus identical antiemetic regimen for chemotherapy-induced gastrointestinal symptom clusters (nausea, vomiting, poor appetite, and xerostomia ). The EA group receives true acupuncture with continuous wave stimulation (2Hz frequency, ≤10mA intensity as tolerated, 30min/session) administered: (1) 1-2h pre-chemotherapy on Day 1, and (2) daily at 9:00-10:00 from Days 2-4. Controls receive sham EA with an identical treatment schedule and the same antiemetics. Assessments during Days 1-5 include: Researchers record the incidence of nausea, vomiting, poor appetite, and xerostomia; Collection of weight, ECOG scores, and EQ-5D-5L questionnaires; documentation of antiemetic/chemotherapy use, concomitant medications, and adverse events; laboratory tests per cycle; and imaging when indicated. Blood samples are preserved every two cycles. Primary/secondary outcomes and adverse events are systematically evaluated.
Interventions
DEVICEelectroacupuncture
The acupuncturist applied needles at four acupoints: Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6), with insertion depths of approximately 20 mm, 15 mm, 20 mm, and 5 mm respectively. Electrical stimulation was delivered in continuous wave mode at 2 Hz frequency with current intensity ≤10 mA (adjusted according to patient tolerance), administered for 30 minutes per session.
DRUGstandard quadruple antiemetic therapy
Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1).
DEVICEsham electroacupuncture
The same acupoints as the electroacupuncture group were referenced, but with sham acupuncture (minimal insertion at non-acupoint locations) and sham electrical stimulation, while maintaining the same treatment duration and course as the electroacupuncture group.
Sponsors
Jiuda Zhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Radiologically and pathologically confirmed stage I-III breast cancer; 2. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1; 3. Age between 18 and 75 years; 4. Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy; 5. No prior acupuncture treatment within one month before enrollment; 6. Voluntary participation in the study with written informed consent obtained; (7) An expected survival of at least 3 months; (8) Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria.
Exclusion criteria
1. Patients with advanced-stage cancer; 2. Those undergoing concurrent chemoradiotherapy; 3. Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy; 4. Patients with contraindications to acupuncture, such as active skin infections; 5. Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment; 6. Patients with a history of xerostomia; 7. Individuals with known allergies to the study drugs; 8. Pregnant or breastfeeding patients; 9. Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation); 10. Patients with seizure disorders requiring anticonvulsant therapy; 11. Those receiving thiazides as chronic antipsychotic medications; 12. Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy. | 120 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy. | 120 hours | — |
| The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle. | 120 hours | — |
| The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle. | 120 hours | — |
| Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle. | 120 hours | — |
| Complete protection rates in the overall, acute, and delayed phases following the first chemotherapy cycle. | 120 hours | — |
| Quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). | 120 hours | The EQ-5D-5L evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored from 1 ("no problems") to 5 ("extreme problems"), with health states expressed as 5-digit codes (e.g., 11111=no impairment; 55555=extreme impairment across all dimensions). Index scores were calculated using the Chinese value set (Luo et al., 2017), yielding a theoretical range of -0.391 (worse than death) to 1.0 (perfect health). The visual analogue scale (VAS) component records self-rated health status from 0 ("worst imaginable health") to 100 ("best imaginable health"). |
Countries
China
Outcome results
None listed