Acupoint Application for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer

Xiu Huang60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Lung Cancer (Diagnosis)Chemotherapy-Induced Nausea and Vomiting

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 24 to 120 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.