A Phase 1/2 interventional study of FADA (active fraction of Ficus septica leaf) 800 mg/day and FADA (active fraction of Ficus septica leaf) 2000 mg/day in Breast Cancer Stage IV, sponsored by Gadjah Mada University. Recruiting at 1 site in Indonesia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Gadjah Mada University · Phase 1/2, Interventional, and Supportive care
The purpose of this research is to assess the safety profile and clinical benefit of Awar-Awar leaf active fraction as a complementary therapy in chemotherapy of stage IV breast cancer
The study uses a double blind design and randomized controlled trial that compares the safety and clinical efficacy profiles of 3 treatment groups (each consists of 97 subjects who received chemotherapy for 6 cycles). The treatment group was given FADA at a dose of 800 mg/day and 2000 mg/day compared to the placebo group. Interim analysis is carried out after 25% of the subjects completed 3 cycles of chemotherapy; whereas interim analysis II is carried out after 50% of the subjects completed 3 cycles of chemotherapy.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 324 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Gadjah Mada University is the lead sponsor of 62 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
receive a plasebo capsule 2 doses per day
Other: Placebo capsule
receive FADA capsules twice a day (each 400 mg)
Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day
receive FADA capsules twice a day (each 1000 mg)
Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day
FADA is given twice a day (total dose of 800 per day per patient)
FADA is given twice a day (total dose of 2000 per day per patient)
Placebo capsule is given twice a day
Quality of life assessment
The change of quality of life index during 6 cycles of chemotherapy (each cycle is 21 days). The score ranges from 0 (best) to 100 (worst).
Time frame: The measurement is at 3-7 days before the 4th cycle of chemotherapy (each cycle is 21 days), and 14-21 days after the 6th cycle (each cycle is 21 days)
Adverse events (AEs) and Serious Adverse Events (SAEs).
Safety data will be collected by monitoring and recording all adverse events (AEs) and Serious Adverse Events(SAEs)
Time frame: throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days)
Plan to share: No
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Gadjah Mada University