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
2 other identifiers
interventional
324
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2021
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFebruary 28, 2024
February 1, 2024
3.2 years
August 5, 2021
February 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Study Arms (3)
Placebo
PLACEBO COMPARATORreceive a plasebo capsule 2 doses per day
FADA 800 mg/day
EXPERIMENTALreceive FADA capsules twice a day (each 400 mg)
FADA 2000 mg/day
EXPERIMENTALreceive FADA capsules twice a day (each 1000 mg)
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gadjah Mada Universitylead
- Ahmad Dahlan Universitycollaborator
- Dr. Kariadi General Hospitalcollaborator
- PT Konimexcollaborator
- LPDP, Kementerian Keuangan, Indonesiacollaborator
Study Sites (1)
Dr. Kariadi General Hospital
Semarang, Central Java, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
dr. Santosa, Ph.D
Dr. Kariadi General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blind; Randomized Controlled Trial
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Pharmaceutical Biology, Faculty of Pharmacy
Study Record Dates
First Submitted
August 5, 2021
First Posted
September 5, 2021
Study Start
October 25, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2025
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share