Using Ficus Septica Leaves to Help Treat Stage IV Breast Cancer
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
This study is testing if a treatment made from Ficus septica leaves can help people with stage IV breast cancer feel better while they are getting chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Gadjah Mada University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Semarang, Jawa Tengah) |
| Trial ID | NCT05033925 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of an active fraction derived from Ficus septica leaves as a complementary therapy for patients undergoing chemotherapy for stage IV breast cancer. It employs a double-blind, randomized controlled design, comparing two different doses of the Ficus septica extract against a placebo in a total of 291 participants. The study will conduct interim analyses to assess progress and safety after a portion of the subjects have completed their chemotherapy cycles.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with stage IV breast cancer who are undergoing chemotherapy.
Not a fit: Patients with liver or kidney disorders, brain metastases, or those who cannot comply with the study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could enhance the effectiveness of chemotherapy and improve outcomes for patients with advanced breast cancer.
How similar studies have performed: While there is limited data on the specific use of Ficus septica in cancer treatment, similar complementary therapies have shown promise in enhancing chemotherapy outcomes in other studies.
Eligibility criteria
Show full inclusion / exclusion 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%
Where this trial is running
Semarang, Jawa Tengah
- Dr. Kariadi General Hospital — Semarang, Jawa Tengah, Indonesia (Recruiting)
Study contacts
- Principal investigator: dr. Santosa, Ph.D — Dr. Kariadi General Hospital
- Study coordinator: Nanang Fakhrudin, Ph.D
- Email: nanangf@ugm.ac.id
- Phone: +62 85878502778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.