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Clinical Study on the Prevention and Treatment of Platinum-Induced CINV with Intradermal Needle Combined with Umbilical Herbal Patch

Clinical Study on the Prevention and Treatment of Platinum-Induced CINV with Intradermal Needle Combined with Umbilical Herbal Patch

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000965
Enrollment
Unknown
Registered
2026-04-16
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-04-28

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 (CINV)

Interventions

Combination group:On the basis of the control group, treatment was combined with intradermal needle and herbal umbilical patch
Intradermal Needle Group:On the basis of the control group, intradermal needle therapy was administered. Device: Seirin brand sterile disposable press needles (manufacturer: Seirin Corporation, Japan
diameter 0.2 mm, lengths 1.5 mm and 1.2 mm). Procedure: Intradermal needle insertion was performed one day before chemotherapy. The patient was placed in a supine position, and the local acupoints wer
Umbilical Herbal Patch Group:On the basis of the control group, umbilical herbal patch therapy was administered. Su Geng (Perillae Caulis) and Zhi Shi (Aurantii Fructus Immaturus) were ground into pow
Control group:Conventional antiemetics recommended by the Chinese Society of Clinical Oncology guidelines for the prevention and treatment of CINV, including 5-HT3 receptor antagonists, NK-1 rece

Sponsors

People's Hospital of Boluo County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18–75 years; (2) Patients with pathologically confirmed malignant tumor according to diagnostic criteria; (3) Requiring chemotherapy with platinum-containing regimens as assessed by physicians; (4) Karnofsky Performance Status (KPS) score =60, and life expectancy >3 months; (5) No use of other antiemetics within 48 hours prior to chemotherapy; (6) Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with significant nausea or vomiting prior to enrollment; (2) Nausea or vomiting caused by neurological or gastrointestinal diseases; (3) Allergy to the herbal umbilical patch; (4) Acupuncture needle phobia or fear of needling; (5) Brain metastases; (6) Mental or cognitive disorders that may hinder cooperation with treatment; (7) Participation in other clinical trials concurrently; (8) Other reasons deemed unsuitable for this clinical trial by the investigators.

Design outcomes

Primary

MeasureTime frame
Index of Nausea, Vomiting and Retching (INVR) scale score;

Secondary

MeasureTime frame
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30);Treatment satisfaction score;

Countries

China

Contacts

Public ContactFei Li

People's Hospital of Boluo County, Huizhou, 516100, China

leephialf@126.com18933471820

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026