Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and Vomiting
Conditions
Keywords
acupoint application, 5-HT3 receptor antagonist, chemotherapy-induced nausea and vomiting, lung cancer, randomized controlled trial, supportive care
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.
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.
Interventions
DRUG5-HT3 receptor antagonist (e.g., ondansetron)
Standard antiemetic prophylaxis for chemotherapy-induced nausea and vomiting.
OTHERAcupoint application
Herbal plaster applied to selected acupoints to alleviate chemotherapy-induced nausea and vomiting.
Sponsors
Xiu Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate of delayed-phase CINV (24-120 h) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLIE quality-of-life score | 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. |
| 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) | 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. |
| MAT nausea score | 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. |
Countries
China
Contacts
CONTACTXIU HUANG
Outcome results
None listed