Breast cancer
Conditions
Interventions
Inner-power arm Inner-power (1pac/day) is administered from Day 1 to Day 21. Day 1 is the day of the administration of chemotherapy.
The control arm Patients only receive the standard chemotherapy
Sponsors
Interfaculty Initiative in Information Studies, The University of Tokyo Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Diagnosed as breast cancer histologically 2) 20 years to 80 years 3) ECOG PS 0-1 4) Patients can answer the questionnaires. 5) Patients are currently under the chemotherapy and are planning to have the same regimen. 6) The fatigue score (BRI q3) was 4 or more in the previous course of the chemotherapy 7) Written consent was obtained
Exclusion criteria
Exclusion criteria: 1) Patients are currently under radiotherapy or interferon therapy 2) Nausea and/or anorexia grades (CTCAE v.4.0) are 3 or more in the previous course of the chemotherapy 3) Uncontrolled anemia 4) Clinically severe heart disease 5) Use of MAO inhibitor and/or central nervous system stimulant 6) Regular use of steroid 7) Mental disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief fatigue inventory (BFI) question 3 (worst level of fatigue) | — |
Secondary
| Measure | Time frame |
|---|---|
| Global fatigue score and other scores of BFI, Hospital Anxiety and Depression scale (HADS), EORTC QLQ-C30 and minimal clinically important difference (MCID) | — |
Countries
Japan
Contacts
Public Contactkota KIHARA
NPO JORTC Operations Office
Outcome results
None listed