NCT05033925

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Gadjah Mada University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FADA (active fraction of Ficus septica leaf) 800 mg/day	FADA is given twice a day (total dose of 800 per day per patient)
DIETARY_SUPPLEMENT	FADA (active fraction of Ficus septica leaf) 2000 mg/day	FADA is given twice a day (total dose of 2000 per day per patient)
OTHER	Placebo capsule	Placebo capsule is given twice a day

Timeline

• Start date: 2021-10-25
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2021-09-05
• Last updated: 2024-02-28

Locations

1 site across 1 country: Indonesia