Clinical trial NCT05033925: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Breast Cancer Stage IV
Keywords: ficus septica
cancer
doxorubicin
adjuvant
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: Ahmad Dahlan University
name: Dr. Kariadi General Hospital
name: PT Konimex
name: LPDP, Kementerian Keuangan, Indonesia
First posted: 2021-09-05
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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%

Primary outcomes:
measure: Quality of life assessment
timeFrame: 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:
measure: Adverse events (AEs) and Serious Adverse Events (SAEs).
timeFrame: throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days)
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi General Hospital
state: Jawa Tengah
Study officials:
affiliation: Dr. Kariadi General Hospital
name: dr. Santosa, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: