Overview
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
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.
Eligibility
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%