Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients

Conditions
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Cancer, Pancreas

Intervention / Treatment
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* Other: Oncothermia
* Drug: FOLFIRINOX or Gemcitabine based chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncothermia<br>Patients with oncothermia treatment and palliative chemotherapy | Other: Oncothermia<br>* Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.<br>Drug: FOLFIRINOX or Gemcitabine based chemotherapy<br>* As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.<br>|
| Active Comparator: Control<br>Patients with palliative chemotherapy only | Drug: FOLFIRINOX or Gemcitabine based chemotherapy<br>* As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of opioid use amount |  | 3 months | 
| change of pain score (VAS score) |  | 3 months | 
| Adverse effect |  | 3 months |