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Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer
Sponsor: Semmelweis University
Summary
The aim of this study is to investigate whether the application of concomitant modulated electro-hyperthermia in a neoadjuvant chemotherapeutic setting is beneficial for patients with HER2-negative, stage II-III breast cancer.
Official title: [A Prospective, Randomized Trial to Assess the Added Value of Concomitant Modulated Electro-hyperthermia in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy - an Investigator Initiated Study]
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2023-02-20
Completion Date
2025-08-31
Last Updated
2024-12-03
Healthy Volunteers
No
Conditions
Interventions
Oncotherm EHY-2030
Oncotherm EHY-2030 is a non-invasive electromagnetic devices with known anti-tumoral effects. It operates in a precision capacitive coupled impedance matched way, working on a radiofrequency of 13.56 MHz. mEHT exploits various biophysical differences of cancer cells. For example, energy absorption on the membrane rafts is different than those of healthy host cells, and damage-associated molecular patterns (DAMPS) will also occur leading to programmed or immunogenic tumor cell death. mEHT can enhance DNA fragmentation of tumor cells, increase the fraction of cells with low mitochondrial membrane potential, increase the concentration of intracellular Ca2+, increase the Fas, c-Jun N-terminal kinases and MAPK/ERK signaling pathways, increase the expression of pro-apoptotic Bcl-2 family proteins and can up-regulate the expression of genes associated with the molecular function of cell death (EGR1, JUN, and CDKN1A) and silencing others associated with cytoprotective functions.
Paclitaxel
weekly paclitaxel for 12 weeks
Carboplatin
added to weekly paclitaxel if patient has triple-negative breast cancer
Cyclophosphamide/Doxorubicin
according to the AC protocol
Breast cancer removal surgery
Either breast-conserving surgery or total mastectomy after the neoadjuvant chemotherapy with or without mEHT (if feasible)
Locations (1)
Division of Oncology, Department of Internal Medicine and Oncology, Semmelweis University
Budapest, Budapest, Hungary