Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo receive a plasebo capsule 2 doses per day |
Other: Placebo capsule
Placebo capsule is given twice a day
|
| Experimental: FADA 800 mg/day receive FADA capsules twice a day (each 400 mg) |
Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day
FADA is given twice a day (total dose of 800 per day per patient)
|
| Experimental: FADA 2000 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 2000 per day per patient)
|
Outcome Measures
Primary Outcome Measures
- Quality of life assessment [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)]
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).
Secondary Outcome Measures
- Adverse events (AEs) and Serious Adverse Events (SAEs). [throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days)]
Safety data will be collected by monitoring and recording all adverse events (AEs) and Serious Adverse Events(SAEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female, at least 18 years old
-
Welfare scale 0, 1, and 2 (ECOG - WHO)
-
Patients with stage IV breast cancer who have histopathological data according to the TNM Classification of Malignant Tumors (TNM) from American Joint Committee on Cancer (AJCC) 8th edition 2017
-
Patients who are willing to participate in the test and sign an informed consent
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Patients who undergo breast cancer chemotherapy with luminal B sub-type or triple negative with anthracycline base
-
Patients who are willing and able to fill out a questionnaire
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The patients who are willing and able to comply with the test protocols during the test
Exclusion Criteria:
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Unable to meet the test protocol
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Patients with liver and kidney disorders
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Patients with other diseases/disorders that are meaningful according to the investigators will be excluded from the test
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Patients with cancer that has metastasized to the brain
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Pregnant women and breastfeeding mothers
-
Patients with the ejection fraction smaller-than or equal to 55%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Kariadi General Hospital | Semarang | Jawa Tengah | Indonesia |
Sponsors and Collaborators
- Gadjah Mada University
- Ahmad Dahlan University
- Dr. Kariadi General Hospital
- PT Konimex
- LPDP, Kementerian Keuangan, Indonesia
Investigators
- Principal Investigator: dr. Santosa, Ph.D, Dr. Kariadi General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UKFC-PU-2019-01-08
- PRJ-82/LPDP/2019