Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer Stage IV

Intervention / Treatment
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* Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day
* Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day
* Other: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>receive a plasebo capsule 2 doses per day | Other: Placebo capsule<br>* Placebo capsule is given twice a day<br>|
| Experimental: FADA 800 mg/day<br>receive FADA capsules twice a day (each 400 mg) | Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day<br>* FADA is given twice a day (total dose of 800 per day per patient)<br>|
| Experimental: FADA 2000 mg/day<br>receive FADA capsules twice a day (each 1000 mg) | Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day<br>* FADA is given twice a day (total dose of 2000 per day per patient)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ficus septica, cancer, doxorubicin, adjuvant