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

Gadjah Mada University324 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

324

Conditions

Breast Cancer Stage IV

Interventions

FADA (active fraction of Ficus septica leaf) 800 mg/dayDIETARY_SUPPLEMENT

FADA is given twice a day (total dose of 800 per day per patient)

FADA (active fraction of Ficus septica leaf) 2000 mg/dayDIETARY_SUPPLEMENT

FADA is given twice a day (total dose of 2000 per day per patient)

Placebo capsuleOTHER

Placebo capsule is given twice a day

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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%

Locations (1)

Dr. Kariadi General Hospital

Semarang, Central Java, Indonesia

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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 Outcomes

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)

Time frame: throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days)

Central Contacts

Nanang Fakhrudin, Ph.D

CONTACT

+62 85878502778 nanangf@ugm.ac.id

Data from ClinicalTrials.gov

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