Exploring the Impact of Meal Kit Intervention on QOL and Metabolome in Patients with Early-Stage Breast Cancer

JRCT ID: jRCT1033240599

Registered date:09/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 09/01/2025
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Subjects will be randomly assigned in a 1:1 ratio to a group using the meal kit for the first 3 months (Group A) and a group using the meal kit for the last 3 months (Group B). Group A will use a meal kit prepared by a registered dietitian for the first 3 months from the start of chemotherapy and receive regular dietary guidance for the next 3 months. Group B will receive regular dietary guidance for the first 3 months and use the meal kit for the last 3 months.

Outcome(s)

• Primary Outcome: Change in the "appetite loss" domain score of the EORTC QLQ-C30

Secondary Outcome

Change in the total score of the EORTC QLQ-C30
Change in the domain scores of the EORTC QLQ-C30
Change in metabolite profiles by plasma metabolome analysis
Change in weight, BMI, and body composition
Change in nutritional status assessment by Subjective Global Assessment (SGA)
Change in serum albumin, hemoglobin, zinc, and vitamin D levels
Completion rate and relative dose intensity of chemotherapy
Incidence rate of adverse events, incidence rate of Grade 3 or higher adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Diagnosed with breast cancer through pathological examination
Diagnosed with clinical stages 0 to III through imaging
Planned to start perioperative chemotherapy (including anthracycline and taxane)
20 years old or older
Performance Status (PS) of 0 or 1
Written consent obtained for participation in this study

Exclude criteria

Cases with excessive food allergies
Cases where written consent for this study was not obtained
Cases with mental disorders deemed difficult to participate in this study
Cases judged inappropriate as study subjects by the principal investigator

Related Information

• Primary Sponsor: Fushimi Atsushi
• Source(s) of Monetary Support: Oisix ra daichi Co., Ltd.