Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors

Yonsei Hyperthermia Study Group20 enrolled

Overview

The main purpose of this study is to evaluate immunogenic effect of hyperthermia applied with flexible electrode-typed 2-MHz device during radiotherapy for solid tumors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor

Interventions

HyperthermiaOTHER

Patients will be treated with hyperthermia 2 or 3 times a week. Treatment will be performed for 1 hours per each visit. Patients will be treated with radiotherapy 5 times a week.

RadiotherapyRADIATION

Patients will be treated with radiotherapy 5 times a week.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Solid tumor (primary, metastatic) * Eastern Cooperative Oncology Group (ECOG) score 0-3 * Ability to understand and the willingness to sign a written informed consent documents Exclusion Criteria: * Myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia within 6 months * Active infectious disease * Pregnant or probability of pregnancy during treatment * Obesity (BMI ≥35) * Immunosuppressive drug after organ transplantation * Autoimmune disease * Skin injury on treatment area

Outcomes

Primary Outcomes

Immunogenic effect

NK cell, CD4+ T cell, CD8+ T cell

Time frame: 1 weeks after treatment

Data from ClinicalTrials.gov

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