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

October 29, 2017 updated by: Seoul National University Hospital

A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Jin-Hyeok Hwang, MD PhD
        • Sub-Investigator:
          • Jaihwan Kim, MD

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

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

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Hospicare Inc.

Investigators

  • Study Chair: Jin-Hyeok Hwang, MD PhD, Seoul National University Bundang Hospital

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 Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 7, 2016

First Submitted That Met QC Criteria

August 7, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 29, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-IMGPB-2016-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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