Malaise
Conditions
Interventions
None listed
Sponsors
Keio University School of Medicine Center for Kampo Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) The patients complaining of fatigue and malaise 2 ) The patients who have completed gynecological cancer (cervical cancer, uterine cancer, ovarian cancer) treatment (surgical operation (pelvic lymph node dissection), chemotherapy, radiotherapy) for more than one month. 3) The patients who were prescribed with Ninjinyoeito under a doctor's diagnosis 4) The patients with documented consent
Exclusion criteria
Exclusion criteria: 1) The patients who are regularly using other Kampo medicine. 2) The patients with stage IV malignancy 3) The patients with PS(Performance Status) of 3 or 4 4) The patients considered to have a prognosis of less than six months 5) The patients with the experience an allergy after taking any Kampo medicine 6) The patients with a remarkable digestive organ symptom 7) The patients diagnosed with major depressive disorder and undergoing prescription adjustment 8) The patients with aldosteronism, myopathy, hypokalemia, or suspected 9) The patients with hepatic dysfunction (AST>80 IU/L or ALT>80 IU/L) 10) The patients who were judged not to be included by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of change, rate of change of the CFS score 12 weeks after the dosage start | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Amount and rate of change in evaluation forms (ECOG-PS, HADS, AIS, The FAACT A/CS) 2) Amount and rate of change of laboratory values measured in routine clinical care at the time of patient visit 3) Amount and rate of change in oxidative stress and antioxidant capacity 4) Associations between insomnia, loss of appetite, and anxiety and improvement in fatigue | — |
Countries
Japan
Contacts
Public ContactYuko Horiba
Keio University School of Medicine Center for Kampo Medicine
Outcome results
None listed