Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
NCT ID: NCT05033925
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
324 participants
INTERVENTIONAL
2021-10-25
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo
receive a plasebo capsule 2 doses per day
Placebo capsule
Placebo capsule is given twice a day
FADA 800 mg/day
receive FADA capsules twice a day (each 400 mg)
FADA (active fraction of Ficus septica leaf) 800 mg/day
FADA is given twice a day (total dose of 800 per day per patient)
FADA 2000 mg/day
receive FADA capsules twice a day (each 1000 mg)
FADA (active fraction of Ficus septica leaf) 2000 mg/day
FADA is given twice a day (total dose of 2000 per day per patient)
Interventions
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FADA (active fraction of Ficus septica leaf) 800 mg/day
FADA is given twice a day (total dose of 800 per day per patient)
FADA (active fraction of Ficus septica leaf) 2000 mg/day
FADA is given twice a day (total dose of 2000 per day per patient)
Placebo capsule
Placebo capsule is given twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* The patients who are willing and able to comply with the test protocols during the test
Exclusion Criteria
* Patients with liver and kidney disorders
* Patients with other diseases/disorders that are meaningful according to the investigators will be excluded from the test
* Patients with cancer that has metastasized to the brain
* Pregnant women and breastfeeding mothers
* Patients with the ejection fraction smaller-than or equal to 55%
18 Years
FEMALE
Yes
Sponsors
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Ahmad Dahlan University
UNKNOWN
Dr. Kariadi General Hospital
UNKNOWN
PT Konimex
UNKNOWN
LPDP, Kementerian Keuangan, Indonesia
UNKNOWN
Gadjah Mada University
OTHER
Responsible Party
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Nanang Fakhrudin
Head of Department of Pharmaceutical Biology, Faculty of Pharmacy
Principal Investigators
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dr. Santosa, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Dr. Kariadi General Hospital
Locations
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Dr. Kariadi General Hospital
Semarang, Central Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRJ-82/LPDP/2019
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UKFC-PU-2019-01-08
Identifier Type: -
Identifier Source: org_study_id
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