- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07768124
Acupoint Application for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer
August 13, 2026 updated by: Xiu Huang
Acupoint Application Combined With 5-HT3 Receptor Antagonist for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer Patients: A Single-Center, Randomized, Controlled Trial
This single-center, randomized, controlled study evaluates whether acupoint application added to standard 5-HT3 receptor antagonist anti-nausea medication improves control of chemotherapy-induced nausea and vomiting in adults with lung cancer receiving first-line platinum-based chemotherapy.
Participants will be randomly assigned to receive either acupoint application plus a 5-HT3 receptor antagonist or the 5-HT3 receptor antagonist alone for one chemotherapy cycle.
The study will compare complete control of delayed nausea and vomiting between the two groups.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Adults with pathologically confirmed lung cancer who are scheduled to receive first-line platinum-based chemotherapy are eligible.
After providing written informed consent, participants are randomized 1:1 to receive either acupoint application using a herbal plaster applied to selected acupoints plus standard 5-HT3 receptor antagonist prophylaxis, or 5-HT3 receptor antagonist prophylaxis alone.
Nausea and vomiting episodes are recorded by participants using patient diaries, and quality of life is assessed with the Functional Living Index-Emesis questionnaire.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiu HUANG
- Phone Number: +8615023119040
- Email: 104100275@qq.com
Study Locations
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, China, 402160
- Recruiting
- The Affiliated Yongchuan Hospital of Chongqing Medical University
-
Contact:
- Xiu HUANG
- Phone Number: +8615023119040
- Email: 104100275@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pathologically or cytologically confirmed lung cancer.
- Scheduled to receive first-line platinum-based chemotherapy.
- Aged 18 to 75 years.
- Karnofsky Performance Status (KPS) score ≥ 60.
- Expected survival ≥ 3 months.
- Voluntarily signed written informed consent.
Exclusion Criteria:
- Known allergy to any component of the acupoint plaster.
- Severe skin disease, infection, or breakdown at the planned acupoint sites. --Pregnant or lactating women.
- Cognitive impairment or psychiatric disorder that prevents completion of study assessments.
- Participation in another interventional clinical trial within 30 days prior to enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupoint application plus 5-HT3 receptor antagonist
Participants receive herbal acupoint plaster applied to selected acupoints plus standard 5-HT3 receptor antagonist prophylaxis before and during one cycle of platinum-based chemotherapy.
|
Standard antiemetic prophylaxis for chemotherapy-induced nausea and vomiting.
Herbal plaster applied to selected acupoints to alleviate chemotherapy-induced nausea and vomiting.
|
|
Active Comparator: 5-HT3 receptor antagonist alone
Participants receive standard 5-HT3 receptor antagonist prophylaxis alone before and during one cycle of platinum-based chemotherapy.
|
Standard antiemetic prophylaxis for chemotherapy-induced nausea and vomiting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete response rate of delayed-phase CINV (24-120 h)
Time Frame: 24 to 120 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
Complete response is defined as no emetic episodes and no rescue antiemetic use during 24 to 120 hours after the first cycle of platinum-based chemotherapy.
The outcome will be compared between the acupoint application plus 5-HT3 receptor antagonist group and the 5-HT3 receptor antagonist alone group.
|
24 to 120 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete response rate of acute-phase CINV (0-24 h)
Time Frame: 0 to 24 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
Complete response is defined as no emetic episodes and no rescue antiemetic use during 0 to 24 hours after the first cycle of platinum-based chemotherapy.
|
0 to 24 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
|
MAT nausea score
Time Frame: During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
Nausea severity measured by the Morrow Assessment of Nausea and Emesis (MAT) questionnaire after the first cycle of platinum-based chemotherapy.
|
During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
|
FLIE quality-of-life score
Time Frame: During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
Quality of life assessed by the Functional Living Index-Emesis (FLIE) questionnaire after the first cycle of platinum-based chemotherapy.
|
During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2026
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
October 15, 2026
Study Registration Dates
First Submitted
August 11, 2026
First Submitted That Met QC Criteria
August 13, 2026
First Posted (Actual)
August 17, 2026
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
August 13, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Signs and Symptoms, Digestive
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Lung Neoplasms
- Vomiting
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Azoles
- Imidazoles
- Indoles
- Heterocyclic Compounds, 3-Ring
- Carbazoles
- Ondansetron
Other Study ID Numbers
- XWFT-2025-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD Sharing Plan: Individual participant data that underlie the results reported in this article will be shared after de-identification.
Data will be available beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal may request access to the data through the corresponding author.
Proposals will be reviewed by the study team to ensure they comply with Chinese data privacy regulations and the informed consent signed by participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.