Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 7, 2016
September 1, 2016
1.4 years
May 24, 2014
September 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ECOG score change
3 months after oncothermia treatment
Secondary Outcomes (1)
Progression free survival rate
3 months later after oncothermia treatment
Study Arms (1)
Oncothermia group
EXPERIMENTALPatients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.
Interventions
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
Eligibility Criteria
You may qualify if:
- Inoperable or recurred pancreatic ductal adenocarcinoma
- After the each cycle of chemotherapy, the disease status was "stable disease"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Hospicare Co., Ltd.collaborator
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Hyeok Hwang, MD PhD
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 24, 2014
First Posted
May 29, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
September 7, 2016
Record last verified: 2016-09