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

March 7, 2022 updated by: Yonsei Hyperthermia Study Group

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperthermia group
Hyperthermia Radiotherapy
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.
Active Comparator: Control
Radiotherapy
Radiation: Radiotherapy
Patients will be treated with radiotherapy 5 times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenic effect
Time Frame: 1 weeks after treatment
NK cell, CD4+ T cell, CD8+ T cell
1 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei Hyperthermia Study Group

Collaborators

Medicon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 10, 2022

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YURO-H8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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