Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 16, 2025
Date Accepted: Oct 13, 2025
Early-stage Breast Cancer Patients' Quality of Life and Metabolomics Analysis in Response to Meal Kit Intervention During Perioperative Chemotherapy: Protocol for a Single-center Phase II Randomized Crossover Trial
ABSTRACT
Background:
Breast cancer patients 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:
To evaluate the impact of a structured meal kit intervention on quality of life and metabolomic profiles in breast cancer patients during perioperative anthracycline and taxane-based chemotherapy.
Methods:
This single-center phase II randomized crossover trial will enroll 20 breast cancer patients scheduled for perioperative chemotherapy at Jikei University Hospital between October 2024 and October 2025. Patients will be randomized 1:1 to receive meal kit intervention either during the first or second 3-month period of chemotherapy. The intervention consists of weekly deliveries of pre-portioned ingredients with dietitian-designed recipes (one 2-serving meal kit during chemotherapy weeks, two during non-chemotherapy weeks). The primary endpoint is change in the EORTC QLQ-C30 "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 weeks), and study completion (24 weeks).
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 meal kit intervention in supporting breast cancer patients during chemotherapy. The findings may help establish evidence-based standards for nutritional support in oncology care. Clinical Trial: jRCT1033240599.
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