Back to resultsEffect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
Primary Purpose
Cancer, Pancreas
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oncothermia
Sponsored by
About this trial
This is an interventional treatment trial for Cancer, Pancreas focused on measuring Pancreatic cancer, Quality of life, Pain
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncothermia group
Arm Description
Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.
Outcomes
Primary Outcome Measures
ECOG score change
Secondary Outcome Measures
Progression free survival rate
Full Information
NCT ID
NCT02150135
First Posted
May 24, 2014
Last Updated
September 4, 2016
Sponsor
Seoul National University Hospital
Collaborators
Hospicare Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02150135
Brief Title
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Hospicare Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pancreas
Keywords
Pancreatic cancer, Quality of life, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oncothermia group
Arm Type
Experimental
Arm Description
Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.
Intervention Type
Other
Intervention Name(s)
Oncothermia
Intervention Description
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
Primary Outcome Measure Information:
Title
ECOG score change
Time Frame
3 months after oncothermia treatment
Secondary Outcome Measure Information:
Title
Progression free survival rate
Time Frame
3 months later after oncothermia treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Hyeok Hwang, MD PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
We'll reach out to this number within 24 hrs