Effect of Oncothermia on Improvement of Quality of Life in Unresectable 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 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.

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Key information

Conditions

Cancer, Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oncothermia

Other

Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

Primary outcomes

ECOG score change

Time frame: 3 months after oncothermia treatment

Secondary outcomes

Progression free survival rate

Time frame: 3 months later after oncothermia treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

Hospicare Co., Ltd.

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 29, 2014
Registry last updated: Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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