Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
NCT02862015 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-10-31
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 a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.
From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.
Conditions
- Cancer, Pancreas
Interventions
- OTHER
-
Oncothermia
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
- DRUG
-
FOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
Sponsors & Collaborators
-
Hospicare Inc.
collaborator UNKNOWN -
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Jin-Hyeok Hwang, MD PhD · Seoul National University Bundang Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2019-07-31
- Completion
- 2019-07-31
Countries
- South Korea
Study Locations
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