Effect Of Oncothermia On Improvement Of Quality Of Life In Unresectable Pancreatic Cancer Patients

Study Overview

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

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.

N/A

Cancer, Pancreas

OTHER: Oncothermia

SNUBH-IMGPB-2014-02

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-09-04
First Submitted that Met QC Criteria 2014-05-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-09-07
First Posted (ESTIMATED) 2014-05-29	Results First Posted N/A	Last Verified 2016-09

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.

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.

Primary Outcome Measures	Measure Description	Time Frame
ECOG score change		3 months after oncothermia treatment

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival rate		3 months later after oncothermia treatment

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Hospicare Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Jin-Hyeok Hwang, MD PhD, Seoul National University Bundang Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record