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

Breast Cancer Stage IV Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05033925
Study type Interventional
Source Gadjah Mada University
Contact Nanang Fakhrudin, Ph.D
Phone +62 85878502778
Email nanangf@ugm.ac.id
Status Recruiting
Phase Phase 1/Phase 2
Start date October 25, 2021
Completion date December 30, 2025
View Details
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