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

Phase 1

Recruiting

• Conditions: Breast Cancer Stage IV
• Interventions: Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day; Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day; Other: Placebo capsule

• Registration Number: NCT05033925
• Lead Sponsor: Gadjah Mada University

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.

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-05
• Study Start: 2021-10-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-24
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 324

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FADA 800 mg/day	FADA (active fraction of Ficus septica leaf) 800 mg/day	receive FADA capsules twice a day (each 400 mg)
FADA 2000 mg/day	FADA (active fraction of Ficus septica leaf) 2000 mg/day	receive FADA capsules twice a day (each 1000 mg)
Placebo	Placebo capsule	receive a plasebo capsule 2 doses per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Dr. Kariadi General Hospital; 🇮🇩 Semarang, Jawa Tengah, Indonesia