Multicenter RCT Of The Clinical Effectiveness Of Oncothermia With Chemotherapy In Metastatic Pancreatic Cancer Patients

Study Overview

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

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.

N/A

Cancer, Pancreas

OTHER: Oncothermia
DRUG: FOLFIRINOX or Gemcitabine based chemotherapy

SNUBH-IMGPB-2016-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-08-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-10-29
First Submitted that Met QC Criteria 2016-08-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-10-31
First Posted (ACTUAL) 2016-08-10	Results First Posted N/A	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Oncothermia Patients with oncothermia treatment and palliative chemotherapy	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.
ACTIVE_COMPARATOR: Control Patients with palliative chemotherapy only	DRUG: FOLFIRINOX or Gemcitabine based chemotherapy As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Oncothermia

Patients with oncothermia treatment and palliative chemotherapy

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.

ACTIVE_COMPARATOR: Control

Patients with palliative chemotherapy only

DRUG: FOLFIRINOX or Gemcitabine based chemotherapy

As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jin-Hyeok Hwang, MD PhD

Phone Number: +82-31-787-7017

Email: woltoong@snu.ac.kr

Study Contact Backup

Name: Jaihwan Kim, MD

Phone Number: +82-31-787-7075

Email: drjaihwan@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Hospicare Inc.

Investigators

STUDY_CHAIR: Jin-Hyeok Hwang, MD PhD, Seoul National University Bundang Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record