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Randomized controlled clinical trial of acupoint application combined with NEPA in preventing chemotherapy-induced nausea and vomiting

Randomized controlled clinical trial of acupoint application combined with NEPA in preventing chemotherapy-induced nausea and vomiting

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000498
Enrollment
Unknown
Registered
2024-09-28
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Breast cancer

Interventions

experimental group:NEPA+Acupoint application therapy
Control group1:NEPA+ DEX + Acupoint application therapy(placebo)
Control group2:NEPA+ Acupoint application therapy(placebo)

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Patients are informed agree and sign the written Informed Consent voluntarily participate; 2) Patients aged 20 to 65 yearsgender is not limited 3) patients with malignant solid tumors by clinically diagnosed ; 4) patients who received a chemotherapy regimen based on anthracycline drugs including but not limited to anthracycline combined with cyclophosphamide as well as any previously administered highly emetic chemotherapy for other malignant tumors; 5) Patients with ECOG score is 0 or 1 and the expected survival time is = 3 months; 6) Patients who plan to undergo the first cycle of chemotherapy based on anthracycline drugs including but not limited to anthracycline combined with cyclophosphamide and/or co use with other low emetic or low potential drugs (including but not limited to 5-fluorouracil methotrexate etc.); 7) Liver and kidney functions were in the normal range(serum transaminase not higher than 2 times the upper limit of normal value and serum creatinine level is not higher than 1.5 times the upper limit of normal value); 8) patients has the ability and willingness to complete diaries and research questionnaires.

Exclusion criteria

Exclusion criteria: 1) Patients with contraindications to chemotherapy; 2) Patients with severe liver and kidney dysfunction; 3) DEX absolute contraindications; 4) NEPA allergy sufferers; 5) Patients with major organ failure such as decompensated heart and lung failure; 6) Patients with other serious illnesses or infections that may be life-threatening during the treatment period; 7) Patients with skin allergies; 8) Pregnant women lactating women or women who may become pregnant; 9) Patients with mental disorders and epilepsy patients; 10) Patients who have participated in any clinical trials within the past 3 months prior to being selected; 11) Other researchers believe that it is not suitable to be included in this trial; 12) There are other health issues that may interfere with CINV symptoms such as gastrointestinal diseases migraines and tinnitus; 13) Symptomatic brain metastasis; 14) Gastrointestinal obstruction or active peptic ulcer; 15) Long term use of systemic corticosteroids (excluding local and inhaled corticosteroids) or any other medication with antiemetic potential;

Design outcomes

Primary

MeasureTime frame
Complete remission rate and complete control rate of delayed nausea and vomiting;

Secondary

MeasureTime frame
Anticipated nausea and vomiting;Complete remission rate and complete control rate of acute nausea and vomiting;Appetite and quality of life;

Countries

China

Contacts

Public ContactYu Fei

Shengjing Hospital of China Medical University

1448089546@qq.com+8618940251956

Outcome results

None listed

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