Clinical trial · Interventional
Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
Safety and Clinical Efficacy Evaluation of Awar-awar Leaves (Ficus Septica Burm. F.) Active Fraction Capsule as Chemotherapy Complement in Stage IV Breast Cancer Patients
NCT05033925CI-TRIAL-00074423unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FADA (active fraction of Ficus septica leaf) 2000 mg/day | Dietary Supplement | — | UNRESOLVED |
| FADA (active fraction of Ficus septica leaf) 800 mg/day | Dietary Supplement | — | UNRESOLVED |
| Placebo capsule | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- receive a plasebo capsule 2 doses per day
- interventionNames
- Other: Placebo capsule
- type
- EXPERIMENTAL
- label
- FADA 800 mg/day
- description
- receive FADA capsules twice a day (each 400 mg)
- interventionNames
- Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day
- type
- EXPERIMENTAL
- label
- FADA 2000 mg/day
- description
- receive FADA capsules twice a day (each 1000 mg)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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: * Unable to meet the test protocol * 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%
References
Publications (0)
Data not yet available
No reference posted for this study.