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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05033925
• Other study ID #: UKFC-PU-2019-01-08
• Secondary ID: PRJ-82/LPDP/2019
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 25, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Gadjah Mada University
• Contact: Nanang Fakhrudin, Ph.D
• Phone: +62 85878502778
• Email: nanangf[@]ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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%

Related Conditions & MeSH terms

• Breast Cancer Stage IV
• Breast Neoplasms

Intervention

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)
• 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

Locations

Country	Name	City	State
Indonesia	Dr. Kariadi General Hospital	Semarang	Jawa Tengah

Sponsors (5)

Lead Sponsor	Collaborator
Gadjah Mada University	Ahmad Dahlan University, Dr. Kariadi General Hospital, LPDP, Kementerian Keuangan, Indonesia, PT Konimex

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessment	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).	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)
Secondary	Adverse events (AEs) and Serious Adverse Events (SAEs).	Safety data will be collected by monitoring and recording all 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)