Breast cancer
Conditions
Sponsors
Toho University Omori Medical Center, Department of Nutrition Therapy Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases of standard treatment according to the breast cancer clinical practice guidelines published by the Japan Breast Cancer Society
Exclusion criteria
Exclusion criteria: 1. Weight loss of 5% or more has been observed in the last 3 months. 2. Highly advanced example (Exclusion example) When there is liver metastasis, deterioration of liver function, jaundice, and ascites. (Exclusion example) When there is lung metastasis and there are clinical symptoms such as pleural effusion and respiratory distress. However, bone metastases and brain metastases are not excluded. 3. If you have a history of ileus or peritoneal dissemination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Presence or absence of diarrhea or allergic symptoms b. Dehydration, symptomatological hypoglycemia, excessive ketosis, gastrointestinal symptoms Nutritional status (body weight, body composition analysis using In Body (BIA), serum albumin, serum cholinesterase, serum transthyretin, CRP), QOL score (EORTCQLQ-CR38 Japanese version, POMS2 Japanese version) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, pathological control rate, surgical transition rate, transition of tumor markers (including serum anti-p53 antibody titer), PET scan in the clinical range, blood glucose and ketone body measurement using FreeStyle Libre outside the hospital for those who wish Give guidance. In addition, for possible cases, serum and urinary ketone bodies and urinary 8-OHdG will be measured. | — |
Countries
Japan
Contacts
Public ContactNaohiro Washizawa
Toho University Omori Medical Center Nutrition Therapy Center
Outcome results
None listed