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

February 24, 2024 updated by: Nanang Fakhrudin, Gadjah Mada University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

324

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nanang Fakhrudin, Ph.D
  • Phone Number: +62 85878502778
  • Email: nanangf@ugm.ac.id

Study Locations

  • Indonesia
    • Jawa Tengah
      • Semarang, Jawa Tengah, Indonesia
        • Recruiting
        • Dr. Kariadi General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
receive a plasebo capsule 2 doses per day
Other: Placebo capsule
Placebo capsule is given twice a day
Experimental: FADA 800 mg/day
receive FADA capsules twice a day (each 400 mg)
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)
Experimental: FADA 2000 mg/day
receive FADA capsules twice a day (each 1000 mg)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Collaborators

Ahmad Dahlan University
Dr. Kariadi General Hospital
PT Konimex
LPDP, Kementerian Keuangan, Indonesia

Investigators

  • Principal Investigator: dr. Santosa, Ph.D, Dr. Kariadi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKFC-PU-2019-01-08
  • PRJ-82/LPDP/2019 (Other Grant/Funding Number: Lembaga Pengelola Dana Pendidikan, Kemenkeu, Indonesia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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