Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients

September 4, 2016 updated by: Jin-Hyeok Hwang, Seoul National University Hospital
Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia. In this study, the investigators tried to show the effect of "Oncothermia" which is more selective to malignant tissue than conventional hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inoperable or recurred pancreatic ductal adenocarcinoma
  • After the each cycle of chemotherapy, the disease status was "stable disease"

Exclusion Criteria:

  • Person who has an experience of hyperthermia treatment
  • Person who has a difficulty of sensing heat
  • Person who has a skin graft or breast reconstruction surgery
  • Person who has a cardiac pacemaker or an implanted metal
  • Pregnant or breast feeding women
  • Person with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
  • Person who was treated with unproved drugs within 6 months
  • Person who have a serious disease which can affect the person's safety
  • Person who do not consent to the study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oncothermia group
Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.
Other: Oncothermia
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ECOG score change
Time Frame: 3 months after oncothermia treatment
3 months after oncothermia treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival rate
Time Frame: 3 months later after oncothermia treatment
3 months later after oncothermia treatment

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Hospicare Co., Ltd.

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

June 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 4, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-IMGPB-2014-02

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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