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

Cancer, Pancreas Clinical Trial

— Oncothermia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862015
• Other study ID #: SNUBH-IMGPB-2016-03
• Status: Recruiting
• Phase: Phase 2
• First received: August 7, 2016
• Last updated: October 29, 2017
• Start date: August 2016
• Est. completion date: July 2019

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: Jin-Hyeok Hwang, MD PhD
• Phone: +82-31-787-7017
• Email: woltoong[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Pancreas
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hospicare Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change		3 months
Secondary	change of opioid use amount		3 months
Secondary	change of pain score (VAS score)		3 months
Secondary	Adverse effect		3 months