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

A Randomized Crossover Trial Exploring the Effects of Meal Kit Intervention on Quality of Life and Metabolome in Early Breast Cancer Patients Undergoing Perioperative Chemotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1033240599
Enrollment
20
Registered
2025-01-09
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer breast cancer, chemotherapy, meal kit intervention, quality of life, metabolomics

Interventions

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
Mealkit

Sponsors

Fushimi Atsushi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Change in the "appetite loss" domain score of the EORTC QLQ-C30

Secondary

MeasureTime frame
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

Contacts

Public ContactAtsushi Fushimi

The Jikei University School of Medicine

fushimi@jikei.ac.jp+81-334331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026