Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients

Cancer, Pancreas Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150135
• Other study ID #: SNUBH-IMGPB-2014-02
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2014
• Last updated: September 4, 2016
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• 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 this study, the investigators tried to show the effect of "Oncothermia" which is more selective to malignant tissue than conventional hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Inoperable or recurred pancreatic ductal adenocarcinoma

• After the each cycle of chemotherapy, the disease status was "stable disease"

Exclusion Criteria:

• Person who has an experience of hyperthermia treatment

• Person who has a difficulty of sensing heat

• Person who has a skin graft or breast reconstruction surgery

• Person who has a cardiac pacemaker or an implanted metal

• Pregnant or breast feeding women

• Person with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months

• Person who was treated with unproved drugs within 6 months

• Person who have a serious disease which can affect the person's safety

• Person who do not consent to the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

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 Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECOG score change		3 months after oncothermia treatment	No
Secondary	Progression free survival rate		3 months later after oncothermia treatment	No