Effect of Oncothermia on Improvement of Quality of Life i... | NCT02150135

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

NCT02150135

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Cancer, Pancreas

Interventions

Oncothermia

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

May 24, 2014

First Submission Date that Met QC Criteria

May 28, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Name	Class
Hospicare Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oncothermia group	Experimental	Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits.	Other: Oncothermia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oncothermia	Other	Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.	Oncothermia group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ECOG score change		3 months after oncothermia treatment

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival rate		3 months later after oncothermia treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Hyeok Hwang, MD PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D010146	Pain

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided