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

Primary Purpose

Breast Cancer Stage IV

Status
Not yet recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
FADA (active fraction of Ficus septica leaf) 800 mg/day
FADA (active fraction of Ficus septica leaf) 2000 mg/day
Placebo capsule
Sponsored by
Gadjah Mada University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Stage IV focused on measuring ficus septica, cancer, doxorubicin, adjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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%

Sites / Locations

  • Dr. Kariadi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

FADA 800 mg/day

FADA 2000 mg/day

Arm Description

receive a plasebo capsule 2 doses per day

receive FADA capsules twice a day (each 400 mg)

receive FADA capsules twice a day (each 1000 mg)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

First Posted
August 5, 2021
Last Updated
August 27, 2021
Sponsor
Gadjah Mada University
Collaborators
Ahmad Dahlan University, Dr. Kariadi General Hospital, PT Konimex, LPDP, Kementerian Keuangan, Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05033925
Brief Title
Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 7, 2021 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University
Collaborators
Ahmad Dahlan University, Dr. Kariadi General Hospital, PT Konimex, LPDP, Kementerian Keuangan, Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage IV
Keywords
ficus septica, cancer, doxorubicin, adjuvant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind; Randomized Controlled Trial
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
receive a plasebo capsule 2 doses per day
Arm Title
FADA 800 mg/day
Arm Type
Experimental
Arm Description
receive FADA capsules twice a day (each 400 mg)
Arm Title
FADA 2000 mg/day
Arm Type
Experimental
Arm Description
receive FADA capsules twice a day (each 1000 mg)
Intervention Type
Dietary Supplement
Intervention Name(s)
FADA (active fraction of Ficus septica leaf) 800 mg/day
Intervention Description
FADA is given twice a day (total dose of 800 per day per patient)
Intervention Type
Dietary Supplement
Intervention Name(s)
FADA (active fraction of Ficus septica leaf) 2000 mg/day
Intervention Description
FADA is given twice a day (total dose of 2000 per day per patient)
Intervention Type
Other
Intervention Name(s)
Placebo capsule
Intervention Description
Placebo capsule is given twice a day
Primary Outcome Measure Information:
Title
Quality of life assessment
Description
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 Outcome Measure Information:
Title
Adverse events (AEs) and Serious Adverse Events (SAEs).
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nanang Fakhrudin, Ph.D
Phone
+62 85878502778
Email
nanangf@ugm.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dr. Santosa, Ph.D
Organizational Affiliation
Dr. Kariadi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Kariadi General Hospital
City
Semarang
State/Province
Jawa Tengah
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Suryo Purnomo
Phone
+62 8122650084
Email
anthonysp@konimex.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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