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

Overview

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.

Full Title of Study: “A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2019

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.

Arms, Groups and Cohorts

  • Experimental: Oncothermia
    • Patients with oncothermia treatment and palliative chemotherapy
  • Active Comparator: Control
    • Patients with palliative chemotherapy only

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Hospicare Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jin-Hyeok Hwang, MD PhD, Study Chair, Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Jin-Hyeok Hwang, MD PhD, +82-31-787-7017, woltoong@snu.ac.kr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.