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

Phase 1

Completed

• Conditions: Cancer, Pancreas
• Interventions: Other: Oncothermia

• Registration Number: NCT02150135
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-29
• Study Start: 2014-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-04
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Inoperable or recurred pancreatic ductal adenocarcinoma
• After the each cycle of chemotherapy, the disease status was "stable disease"

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncothermia group	Oncothermia	Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.

Primary Outcome Measures

Name	Time	Method
ECOG score change	3 months after oncothermia treatment

Secondary Outcome Measures

Name	Time	Method
Progression free survival rate	3 months later after oncothermia treatment

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of