Breast Cancer Stage IV
Conditions
Keywords
ficus septica, cancer, doxorubicin, adjuvant
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
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.
Interventions
DIETARY_SUPPLEMENTFADA (active fraction of Ficus septica leaf) 800 mg/day
FADA is given twice a day (total dose of 800 per day per patient)
DIETARY_SUPPLEMENTFADA (active fraction of Ficus septica leaf) 2000 mg/day
FADA is given twice a day (total dose of 2000 per day per patient)
OTHERPlacebo capsule
Placebo capsule is given twice a day
Sponsors
Ahmad Dahlan University
Dr. Kariadi General Hospital
PT Konimex
LPDP, Kementerian Keuangan, Indonesia
Gadjah Mada University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind; Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Indonesia
Contacts
Primary ContactNanang Fakhrudin, Ph.D
Outcome results
None listed