Effect of Acupuncture for Loss of Appetite in Advanced Lung Cancer Undergoing Immunotherapy: Protocol of a Randomized Controlled Trial

Background: Loss of appetite (LOA) is a highly prevalent and distressing symptom in advanced lung cancer, leading to malnutrition, poorer treatment tolerance, and reduced quality of life. Although acupuncture may help manage cancer-related symptoms, its effect on LOA in patients receiving immunotherapy is unclear. This study aims to assess the efficacy and safety of acupuncture for alleviating LOA in this population. Methods: This multicenter, randomized, double-blind, sham-controlled trial will enroll 80 eligible patients with advanced lung cancer undergoing immunotherapy who experience LOA, defined as a Visual Analogue Scale (VAS) score ≥30 mm. Participants will be randomly assigned to either true acupuncture or sham acupuncture in a 1:1 ratio, administered over 24 sessions within a 12-week period. The primary outcome is the LOA response rate at week 12. Secondary outcomes include changes in LOA severity, nutritional and hematologic markers, patient-reported measures (appetite/cachexia, disease symptoms, psychological distress, and sleep), and tumor response. Safety and blinding success will also be assessed. Data will be analyzed using SPSS 20.0 and R software. Discussion: To our knowledge, this is the first rigorously designed trial evaluating acupuncture for LOA in advanced lung cancer patients undergoing immunotherapy. The findings may inform integrative supportive care strategies for this patient population.