Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05889390
PHASE2/PHASE3

Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer

Sponsor: Semmelweis University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DRUG

Paclitaxel

weekly paclitaxel for 12 weeks

DRUG

Carboplatin

added to weekly paclitaxel if patient has triple-negative breast cancer

DRUG

Cyclophosphamide/Doxorubicin

according to the AC protocol

PROCEDURE

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