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

NCT ID: NCT02150135

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-11-30

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.

Conditions

Cancer, Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oncothermia group

Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.

Group Type: EXPERIMENTAL

Oncothermia

Intervention Type: OTHER

Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

Interventions

Oncothermia

Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospicare Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Hyeok Hwang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Hyeok Hwang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

SNUBH-IMGPB-2014-02

Identifier Type: -

Identifier Source: org_study_id