Quality of Life and Metabolomics Analysis in Response to Meal Kit Intervention During Perioperative Chemotherapy in Patients with Early-Stage Breast Cancer: Protocol for a Single-Center Phase ? Randomized Crossover Trial #MMPMID41343840
Fushimi A; Taguchi E; Kamio M; Kazama T; Fuke A; Nogi H
JMIR Res Protoc 2025[Dec]; 14 (?): e72715 PMID41343840show ga
BACKGROUND: Patients with breast cancer undergoing chemotherapy experience significant adverse effects, including fatigue, nausea, and taste alterations, leading to malnutrition in 40% of patients. Traditional nutritional counseling has shown limited effectiveness in addressing these challenges during treatment. OBJECTIVE: This study aimed to evaluate the impact of a structured meal kit intervention on quality of life and metabolomic profiles in patients with breast cancer during perioperative anthracycline and taxane-based chemotherapy. METHODS: This single-center phase 2 randomized crossover trial will enroll 20 patients with breast cancer scheduled for perioperative chemotherapy at Jikei University Hospital between October 2024 and October 2025. Patients will be randomized 1:1 to receive a meal kit intervention either during the first or second 3-month period of chemotherapy. The intervention consists of weekly deliveries of preportioned ingredients with dietitian-designed recipes (one 2-serving meal kit during chemotherapy weeks, two during nonchemotherapy weeks). The primary endpoint is the change in the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) "appetite loss" domain score. Secondary endpoints include changes in total EORTC QLQ-C30 score, plasma metabolome profiles, body composition, nutritional status, and chemotherapy completion rate. Data will be collected at baseline, crossover (12 wk), and study completion (24 wk). RESULTS: The study was funded in March 2024. Data collection began on March 26, 2025, and as of manuscript submission, 11 participants have been recruited out of the planned 20 participants. Data analysis has not yet commenced, and results are expected to be published in Spring 2026. CONCLUSIONS: This trial will provide evidence for the effectiveness of a meal kit intervention in supporting patients with breast cancer during chemotherapy. The findings may help establish evidence-based standards for nutritional support in oncology care.
JMIR+Res+Protoc 2025 ; 14 (?): e72715
