Percent Weight Change in the Medical Supplement Group of Early Breast Cancer

Launched by DEPARTMENT OF MEDICAL SERVICES MINISTRY OF PUBLIC HEALTH OF THAILAND · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how taking a medical supplement during chemotherapy affects weight changes in women with early-stage breast cancer. Specifically, it aims to compare the weight change before and after treatment in two groups: one group will receive the supplement daily, while the other group will get nutritional advice. The study is currently recruiting participants, and it is open to women aged 65 to 74 who have been diagnosed with stage I to III breast cancer and are undergoing specific chemotherapy treatments at Rajavithi Hospital.

To be eligible for the trial, participants must have a confirmed diagnosis of breast cancer and be in good health, meaning they should have a heart function score of at least 60% and a good performance status (ECOG score of 0-1). However, women who are pregnant, severely malnourished, or have certain other health conditions, such as advanced breast cancer or diabetes requiring insulin, cannot participate. Those who join the trial can expect to either receive a daily medical supplement or nutritional advice throughout their chemotherapy treatment, helping to understand how these options may affect their weight during this important time.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histopathological confirmed diagnosis of breast cancer
• • Breast cancer stage I-III
• • Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital
• • LVEF \>= 60% - ECOG score 0-1
• Exclusion Criteria:
• • No indication for chemotherapy
• • Contraindication for chemotherapy
• • Breast cancer stage IV
• • Diabetic mellitus who requires insulin injection
• • BMI \>= 30 kg/m2 or \<= 16 kg/m2
• • Previously known other malignancies
• • Second primary cancer
• • Previously received chemotherapy or radiotherapy
• • Severe malnutrition with administration of TPN is indicated
• • Pregnancy or lactation
• • CKD stage 4-5