Clinical trial · Interventional
Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Pancreas | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX or Gemcitabine based chemotherapy | Drug | — | UNRESOLVED |
| Oncothermia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oncothermia
- description
- Patients with oncothermia treatment and palliative chemotherapy
- interventionNames
- Other: Oncothermia
- Drug: FOLFIRINOX or Gemcitabine based chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Patients with palliative chemotherapy only
- interventionNames
- Drug: FOLFIRINOX or Gemcitabine based chemotherapy
Primary outcomes (1)
- measure
- European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available