NCT07768124

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jul 2026Oct 2026

Study Start

First participant enrolled

July 15, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 11, 2026

Last Update Submit

August 13, 2026

Conditions

Keywords

acupoint application5-HT3 receptor antagonistchemotherapy-induced nausea and vomitinglung cancerrandomized controlled trialsupportive care

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    0 to 24 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)

  • MAT nausea score

    During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)

  • FLIE quality-of-life score

    During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)

Study Arms (2)

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.

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.

Drug: 5-HT3 receptor antagonist (e.g., ondansetron)

Interventions

Standard antiemetic prophylaxis for chemotherapy-induced nausea and vomiting.

5-HT3 receptor antagonist aloneAcupoint application plus 5-HT3 receptor antagonist

Herbal plaster applied to selected acupoints to alleviate chemotherapy-induced nausea and vomiting.

Acupoint application plus 5-HT3 receptor antagonist

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Yongchuan Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 402160, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsVomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Chief Physician, Department of Oncology

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 17, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

August 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Locations