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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible 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 be 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%
Clareo Health | Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients