Cancer, Pancreas
Conditions
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 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.
Interventions
OTHEROncothermia
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
DRUGFOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
Sponsors
Hospicare Inc.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pathologically confirmed pancreatic adenocarcinoma * Patients with radiologically identified metastasis (CT or MRI) * Patients with no history of previous chemotherapy * Patients with ECOG score 0-2
Exclusion criteria
* Patients who have an experience of hyperthermia treatment * Patients who have a difficulty of sensing heat * Patients who have a skin graft or breast reconstruction surgery * Patients who have a cardiac pacemaker or an implanted metal * Pregnant or breast feeding women * Patients with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months * Patients who were treated with unproved drugs within 30 days * Patients who have a serious disease which can affect the person's safety * Patients who do not consent to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| change of opioid use amount | 3 months |
| change of pain score (VAS score) | 3 months |
| Adverse effect | 3 months |
Countries
South Korea
Contacts
Primary ContactJin-Hyeok Hwang, MD PhD
Backup ContactJaihwan Kim, MD
Outcome results
None listed