None listed
Conditions
Interventions
Drug : Study participants will take one sachet of Citrulline Malate (1 mg/10 mL) three times a day for a period of one month (less than 4 weeks), starting from the first day of PARP inhibitor administ
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Age = 19 years 2) Patient with epithelial ovarian, tubal, and primary peritoneal cancer planned to receive PARPi maintenance therapy A. 1st line and 2nd line maintenance therapy are eligible B. 1 - 3 previous lines of chemotherapy are eligible 3) Absence of chronic fatigue/asthenia 4) ECOG performance status : 0-3 5) Adequate organ function A. WBC = 3,000/mm3 B. Hb = 9 g/dL C. Platelets = 90,000/mm3 D. Creatinine = 2.0 mg/dL E. Bilirubin = 1.5 x institutional upper limit normal F. SGOT, SGPT, and ALP = 2.5 x institutional upper limit normal 6) Patients must voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Serious underlying disease or complications 2) Myasthenia gravis 3) Chronic fatigue 4) Pregnant or breastfeeding woman *Patients should avoid concomitant use of drugs, herbal supplements and/or ingestion of foods known to modulate CYP3A4 enzyme activity from the time they enter the screening period until 30 days after the last dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of fatigue/asthenia | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade 3, 4 fatigue/asthenia | — |
Countries
Korea, Republic of
Contacts
Public ContactYaesol Kim
Asan Medical Center
Outcome results
None listed