Female breast cancer patient undergoing anticancer treatment presenting with anorexia
Conditions
Interventions
Administer mirtazapine (15mg) 0.5 tablet once daily at bedtime, with an increase to 1 tablet after 7 days. Continue administration once daily at bedtime for a total of 56 consecutive days from the ini
Sponsors
Katayama Hideki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (i) Female with breast cancer patients. (ii) Patients who are 18 years of age or older at the time of consent. (iii) Patients with decreased appetite (FAACT-ACS score = 45ml/min/1.73m2). (ix) Patients who have been fully informed of the study and who have given written consent of their own free will after sufficient understanding of the study.
Exclusion criteria
Exclusion criteria: (i) Patients allergic to mirtazapine-containing ingredients. (ii) Patients receiving other antidepressants, including MAO inhibitors, or within 2 weeks of discontinuation. (iii) Patients with a history of discontinuation of mirtazapine due to adverse drug reactions after previous use. (iv) Patients with central nervous system metastases. (v) Patients who underwent intensive nutritional guidance or exercise intervention that resulted in weight gain or loss within four weeks prior to the start of the study. (vi) Other patients deemed inappropriate as research subjects by the principal investigator and subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of improvement in the ACS (anorexia-cachexia subscale) score of the Functional Assessment of Anorexia/cachexia therapy (FAACT) after 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Degree of improvement in the ACS score of the FAACT after 8 weeks (ii) FAACT after 4 and 8 weeks (iii)Nutritional impact symptom (NIS) at 4 and 8 weeks (iv) Alb and lean body mass after 4 and 8 weeks (v) Area of the psoas major muscle at the third lumbar vertebra (sum of long and short axes on both sides) by abdominal CT at 8 weeks (vi)Adverse events | — |
Contacts
Public ContactHideki Katayama
Okayama University Hospital
Outcome results
None listed