NCT05282784

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 7, 2022

Last Update Submit

March 7, 2022

Conditions

Solid Tumor

Keywords

RadiotherapyHyperthermia

Outcome Measures

Primary Outcomes (1)

  • Immunogenic effect

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

    1 weeks after treatment

Study Arms (2)

Hyperthermia group

EXPERIMENTAL

Hyperthermia Radiotherapy

Other: HyperthermiaRadiation: Radiotherapy

Control

ACTIVE COMPARATOR

Radiotherapy

Radiation: Radiotherapy

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.

Hyperthermia group
RadiotherapyRADIATION

Patients will be treated with radiotherapy 5 times a week.

ControlHyperthermia group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperthermia

Interventions

DiathermyRadiotherapy

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

March 10, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03