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Efficacy and Safety of Self-Powered Press Needle in Preventing and Treating Chemotherapy-Induced Nausea and Vomiting in Patients with Gastrointestinal Malignancies: A Multicenter Open-Label Randomized Controlled Trial

Efficacy and Safety of Self-Powered Press Needle in Preventing and Treating Chemotherapy-Induced Nausea and Vomiting in Patients with Gastrointestinal Malignancies: A Multicenter Open-Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001248
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced nausea and vomiting

Interventions

Experimental group 1:Conventional press needles and conventional treatment
Control group:Conventional treatment
Experimental group 2:Self-powered press needles and conventional treatment

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily participates and signs the informed consent form; (2) Aged 18 to 80 years (inclusive) regardless of gender; (3) Diagnosed with gastrointestinal malignancies (gastric cancer or colorectal cancer) according to established diagnostic criteria; (4) Receiving a two-drug chemotherapy regimen containing oxaliplatin or irinotecan; (5) Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; (6) Life expectancy of =3 months.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of mental illness cognitive impairment or communication disorders; (2) Patients with liver or kidney dysfunction or severe cardiovascular diseases; (3) Patients with nausea and vomiting caused by other factors such as malignant tumor brain metastasis increased intracranial pressure anxiety disorders depression gastrointestinal obstruction Meniere's disease etc; (4) Patients with pacemakers or other electrical stimulation devices abnormal coagulation function severe skin diseases lesions at the acupuncture site fear of acupuncture or allergies to acupuncture or stainless steel needles; (5) Patients who have already received other Traditional Chinese Medicine treatments for chemotherapy-induced nausea and vomiting such as acupoint application massage or auricular therapy.

Design outcomes

Primary

MeasureTime frame
Control of chemotherapy-induced nausea and vomiting;

Secondary

MeasureTime frame
Functional Status;Fatigue;Quality of Life;Performance Status;Time to First Vomiting Episode and Duration of Vomiting;Traditional Chinese Medicine Syndrome Score;

Countries

China

Contacts

Public ContactXiao-Lan Zhang

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

ella1108@sina.cn+8613588771108

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026