Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and VomitingNCT07768124
Acupoint Application for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer
A study testing 5-HT3 receptor antagonist (e.g., ondansetron) and Acupoint application in people with Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and Vomiting, run by Xiu Huang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- 5-HT3 receptor antagonist (e.g., ondansetron) and Acupoint application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Yongchuan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 402160
Xiu HUANG, +8615023119040, 104100275@qq.com
About this study
Official title: 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.
Read the 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.
- Being tested
- 5-HT3 receptor antagonist (e.g., ondansetron), Acupoint application
- Keywords
- acupoint application, 5-HT3 receptor antagonist, chemotherapy-induced nausea and vomiting, lung cancer, randomized controlled trial, supportive care
- Medical subject headings
- Lung Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-HT3 receptor antagonist (e.g., ondansetron)Drug
Standard antiemetic prophylaxis for chemotherapy-induced nausea and vomiting.
Acupoint applicationOther
Herbal plaster applied to selected acupoints to alleviate chemotherapy-induced nausea and vomiting.
| Study group | Role | What they receive |
|---|---|---|
| Acupoint application plus 5-HT3 receptor antagonist | Experimental | 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. Receives: Drug: 5-HT3 receptor antagonist (e.g., ondansetron); Other: Acupoint application |
| 5-HT3 receptor antagonist alone | Active comparator | Participants receive standard 5-HT3 receptor antagonist prophylaxis alone before and during one cycle of platinum-based chemotherapy. Receives: Drug: 5-HT3 receptor antagonist (e.g., ondansetron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate of delayed-phase CINV (24-120 h)
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.
Measured: 24 to 120 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
Secondary outcomes (3)
Complete response rate of acute-phase CINV (0-24 h)
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.
Measured: 0 to 24 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
MAT nausea score
Nausea severity measured by the Morrow Assessment of Nausea and Emesis (MAT) questionnaire after the first cycle of platinum-based chemotherapy.
Measured: During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
FLIE quality-of-life score
Quality of life assessed by the Functional Living Index-Emesis (FLIE) questionnaire after the first cycle of platinum-based chemotherapy.
Measured: During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 Jul 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiu Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiu Huang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768124
- Sponsor's protocol ID
- XWFT-2025-001
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Application Combined With 5-HT3 Receptor Antagonist for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer Patients: A Single-Center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07768124
- Acronym / sponsor ID
- XWFT-2025-001
- Keywords
- acupoint application, 5-HT3 receptor antagonist, chemotherapy-induced nausea and vomiting, lung cancer, randomized controlled trial, supportive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiu HuangUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint application plus 5-HT3 receptor antagonist | Experimental | Drug: 5-HT3 receptor antagonist (e.g., ondansetron), Other: Acupoint applicationParticipants receive herbal acupoint plaster applied to selected acupoints plus standard 5-HT3 receptor antagonist prophylaxis before and during one cycle of platinum-based chemotherapy. |
| 5-HT3 receptor antagonist alone | Active comparator | Drug: 5-HT3 receptor antagonist (e.g., ondansetron)Participants receive standard 5-HT3 receptor antagonist prophylaxis alone before and during one cycle of platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-HT3 receptor antagonist (e.g., ondansetron)Standard antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. | Drug | 5-HT3 receptor antagonist alone, Acupoint application plus 5-HT3 receptor antagonist |
| Acupoint applicationHerbal plaster applied to selected acupoints to alleviate chemotherapy-induced nausea and vomiting. | Other | Acupoint application plus 5-HT3 receptor antagonist |
Primary outcome
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.
3 secondary outcomes
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)
MAT nausea score
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-HT3 receptor antagonist (e.g., ondansetron) and Acupoint application in people with Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and Vomiting, run by Xiu Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XIU HUANG (+8615023119040, 104100275@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.