Viscum Album for TNBC on Adjuvant Pembrolizumab
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorIlsan Cha hospital
About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery.
The main questions it aims to answer are:
Does the addition of Viscum album improve clinical outcomes when combined with pembrolizumab as adjuvant chemotherapy? Is Viscum album safe and tolerable for use in this patient population?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older
Histologically confirmed diagnosis of triple-negative breast cancer
ECOG Performance Status of 0 or 1
Completed surgery and radiotherapy for localized disease, and either (a) requires adjuvant chemotherapy including immune checkpoint inhibitors, or (b) has initiated such therapy within 3 cycles
Disqualifiers
Presence of distant metastasis
Uncontrolled pleural effusion, ascites, or pericardial effusion
Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function
Pregnant or breastfeeding women
Trial design
Design model
Parallel
Treatments tested in this trial
viscum album
DrugActive Ingredient: Viscum album Excipients: Ascorbic acid, disodium phosphate dihydrate, monosodium phosphate monohydrate Formulation: Injectable solution contained in a colorless ampoule; the solution is colorless to pale yellow and clear. Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation according to the following protocol.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Viscum album groupExperimental treatment 1 intervention
Group B: Wait-list control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
cytokine panel
the result of immune-related cytokine panel kit (CCL2, CCL3, CCL4, CD40 Ligand, CXCL10, GM-CSF, Granzyme B, IFN-α, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-4, IL-6, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17, IL-33, PD-L1, TNF-α)
Time frame
week 1, week 4, week 7, week 19Secondary outcomes
1
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
The EORTC QLQ-C30 is a validated, widely used questionnaire developed by the European Organisation for Research and Treatment of Cancer to assess health-related quality of life in cancer patients. It includes 30 items covering functional status, symptoms, and global health and has been validated across multiple languages and cancer populations.
Time frame
week 1, week 4, week 7, week 192
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast 23
The EORTC QLQ-BR23 is a validated breast cancer-specific module designed to be used alongside the EORTC QLQ-C30. It includes 23 items that assess breast cancer-related symptoms, treatment side effects, body image, and sexual functioning, and has been validated in diverse cultural and clinical settings.
Time frame
week 1, week 4, week 7, week 193
MD Anderson Symptom Inventory - core
The MD Anderson Symptom Inventory (MDASI) is a validated patient-reported outcome measure developed by MD Anderson Cancer Center to assess the severity of cancer-related symptoms and their impact on daily functioning. It consists of 13 symptom severity items and 6 interference items.
Time frame
week 1, week 4, week 7, week 19Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov