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

Phase 2

• Conditions: Cancer, Pancreas
• Interventions: Other: Oncothermia; Drug: FOLFIRINOX or Gemcitabine based chemotherapy

• Registration Number: NCT02862015
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-07
• Study First Submitted QC: 2016-08-07
• Study First Posted: 2016-08-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oncothermia	Oncothermia	Patients with oncothermia treatment and palliative chemotherapy
Control	FOLFIRINOX or Gemcitabine based chemotherapy	Patients with palliative chemotherapy only
Oncothermia	FOLFIRINOX or Gemcitabine based chemotherapy	Patients with oncothermia treatment and palliative chemotherapy

Primary Outcome Measures

Name	Time	Method
European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change	3 months

Secondary Outcome Measures

Name	Time	Method
change of opioid use amount	3 months
Adverse effect	3 months
change of pain score (VAS score)	3 months

Trial Locations

Locations (1)

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