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

Gadjah Mada University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer Stage IV

Treatments: Other: Placebo capsule; Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day; Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT05033925

PRJ-82/LPDP/2019 (Other Grant/Funding Number)

UKFC-PU-2019-01-08

Details and patient eligibility

About

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

Full 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.

Enrollment: 324 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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%

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

receive a plasebo capsule 2 doses per day

Treatment:

Other: Placebo capsule

FADA 800 mg/day

Experimental group

Description:

receive FADA capsules twice a day (each 400 mg)

Treatment:

Dietary Supplement: FADA (active fraction of Ficus septica leaf) 800 mg/day

FADA 2000 mg/day

Experimental group

Description:

receive FADA capsules twice a day (each 1000 mg)

Treatment:

Dietary Supplement: FADA (active fraction of Ficus septica leaf) 2000 mg/day