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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Cancer, Pancreas

Treatments: Other: Oncothermia; Drug: FOLFIRINOX or Gemcitabine based chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02862015

SNUBH-IMGPB-2016-03

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Oncothermia

Experimental group

Description:

Patients with oncothermia treatment and palliative chemotherapy

Treatment:

Other: Oncothermia

Drug: FOLFIRINOX or Gemcitabine based chemotherapy

Control

Active Comparator group

Description:

Patients with palliative chemotherapy only

Treatment:

Drug: FOLFIRINOX or Gemcitabine based chemotherapy