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To explore the effectiveness and safety of dexamethasone replacement or reduction and efficiency increase based on the standard two drug regimen for the prevention of moderately emetogenic CINV

A prospective randomized controlled, open label, pilot study: efficacy and safety of NK-1 RA compared with dexamethasone and dexamethasone plus acupoint application of Traditional Chinese Medicine in the prevention of moderately emetogenic CINV

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054821
Enrollment
Unknown
Registered
2021-12-28
Start date
2021-04-20
Completion date
Unknown
Last updated
2022-12-12

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

Group A:5-HT3 RA+NK-1 RA
Group B:5-HT3 RA+Dexamethasone
Group C:5-HT3 RA+Dexamethasone +Acupoint Application of Traditional Chinese Medicine Group

Sponsors

General Hospital of Southern Theatre Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. No gender restriction, aged >= 18 years, and pathologically diagnosed malignant tumors need to receive a medium emetic risk drug chemotherapy regimen; 2. ECOG physical status score 0~2; 3. No obvious abnormality in liver and kidney function, blood routine, electrocardiogram and other tests before chemotherapy, (liver and kidney function: creatinine 85 x 10^9/L, neutrophils > 1.5 x 10^9/L, leukocytes > 3.5 x 10^9/L); 4. The predicted survival period is more than 3 months; 5. No nausea or vomiting caused by tumor factors one week before enrollment, and no contraindications to chemotherapy; 6. Understand and voluntarily participate in this research and sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Long-term use of hormones; 2. Patients with vomiting 24 hours before chemotherapy; 3. Patients who are pregnant or breastfeeding; 4. Those who are allergic to 5-HT3 RA, NK-1 RA, dexamethasone, and traditional Chinese medicine patches; 5. Nausea and vomiting caused by other non-tumor factors, those who are taking other emetic drugs or alcoholism.

Design outcomes

Secondary

MeasureTime frame
Safety evaluation;Quality of life of cancer patients;

Primary

MeasureTime frame
rate of complete remission of vomiting;Nausea complete control rate;

Countries

China

Contacts

Public ContactNie Wuyi

General Hospital of Southern Theater Command

yukawayukiho@qq.com+86 18566781502

Outcome results

None listed

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