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NCT05282784 Clinical Trial

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

Solid Tumor Clinical Trial

Official title:
Exploratory, Open-labelled, Control Group-included, Single Institution Clinical Trial for Evaluating Immunogenic Effect of Hyperthermia Applied With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05282784
Other study ID # YURO-H8
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 10, 2022
Est. completion date April 30, 2022

Study information
Verified date March 2022
Source Yonsei Hyperthermia Study Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Hyperthermia
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.
Radiation:
• Radiotherapy
Patients will be treated with radiotherapy 5 times a week.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Yonsei Hyperthermia Study Group Medicon, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Immunogenic effect NK cell, CD4+ T cell, CD8+ T cell 1 weeks after treatment
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