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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02150135
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : September 7, 2016
Hospicare Co., Ltd.
Information provided by (Responsible Party):
Jin-Hyeok Hwang, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer, Pancreas Other: Oncothermia Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

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 :
  1. ECOG score change [ Time Frame: 3 months after oncothermia treatment ]

Secondary Outcome Measures :
  1. Progression free survival rate [ Time Frame: 3 months later after oncothermia treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02150135

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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Hospicare Co., Ltd.
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Principal Investigator: Jin-Hyeok Hwang, MD PhD Seoul National University Bundang Hospital
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Responsible Party: Jin-Hyeok Hwang, Professor, Seoul National University Hospital Identifier: NCT02150135    
Other Study ID Numbers: SNUBH-IMGPB-2014-02
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Keywords provided by Jin-Hyeok Hwang, Seoul National University Hospital:
Pancreatic cancer
Quality of life
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases