Breast Cancer Stage IVPhase 1/2NCT05033925
Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
A Phase 1/2 study testing FADA (active fraction of Ficus septica leaf) 800 mg/day and FADA (active fraction of Ficus septica leaf) 2000 mg/day in people with Breast Cancer Stage IV, run by Gadjah Mada University at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Stage IV
- What is being tested?
- FADA (active fraction of Ficus septica leaf) 800 mg/day and FADA (active fraction of Ficus septica leaf) 2000 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Oct 2021to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Kariadi General Hospital
Semarang, Central Java
Anthony Suryo Purnomo, +62 8122650084, anthonysp@konimex.com
About this study
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
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
Read the 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.
- Conditions
- Breast Cancer Stage IV
- Being tested
- FADA (active fraction of Ficus septica leaf) 800 mg/day, FADA (active fraction of Ficus septica leaf) 2000 mg/day, Placebo capsule
- Keywords
- ficus septica, cancer, doxorubicin, adjuvant
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | receive a plasebo capsule 2 doses per day Receives: Other: Placebo capsule |
| FADA 800 mg/day | Experimental | receive FADA capsules twice a day (each 400 mg) Receives: Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day |
| FADA 2000 mg/day | Experimental | receive FADA capsules twice a day (each 1000 mg) Receives: Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (1)
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)
Measured: throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Oct 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmad Dahlan University, Dr. Kariadi General Hospital, PT Konimex, LPDP, Kementerian Keuangan, Indonesia
- Responsible party
- Principal investigator, Nanang Fakhrudin, Gadjah Mada University
- Investigators
- dr. Santosa, Ph.D, Principal investigator, Dr. Kariadi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033925
- Sponsor's protocol ID
- UKFC-PU-2019-01-08
- Other IDs
- PRJ-82/LPDP/2019
- Status last verified
- Feb 2024
- First submitted
- 5 Aug 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05033925
- Acronym / sponsor ID
- UKFC-PU-2019-01-08
- Conditions
- Breast Cancer Stage IV
- Keywords
- ficus septica, cancer, doxorubicin, adjuvant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Ahmad Dahlan University, Dr. Kariadi General Hospital, PT Konimex, LPDP, Kementerian Keuangan, Indonesia
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo capsulereceive a plasebo capsule 2 doses per day |
| FADA 800 mg/day | Experimental | Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/dayreceive FADA capsules twice a day (each 400 mg) |
| FADA 2000 mg/day | Experimental | Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/dayreceive FADA capsules twice a day (each 1000 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FADA (active fraction of Ficus septica leaf) 800 mg/dayFADA is given twice a day (total dose of 800 per day per patient) | Dietary supplement | FADA 800 mg/day |
| FADA (active fraction of Ficus septica leaf) 2000 mg/dayFADA is given twice a day (total dose of 2000 per day per patient) | Dietary supplement | FADA 2000 mg/day |
| Placebo capsulePlacebo capsule is given twice a day | Other | Placebo |
Primary outcome
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).
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dr. Santosa, Ph.D principal investigator
Dr. Kariadi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FADA (active fraction of Ficus septica leaf) 800 mg/day and FADA (active fraction of Ficus septica leaf) 2000 mg/day in people with Breast Cancer Stage IV, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nanang Fakhrudin, Ph.D (+62 85878502778, nanangf@ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.