Cancer, PancreasPhase 1NCT02150135
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
A Phase 1 study testing Oncothermia in people with Cancer, Pancreas, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer, Pancreas
- What is being tested?
- Oncothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inoperable or recurred pancreatic ductal adenocarcinoma
- After the each cycle of chemotherapy, the disease status was "stable disease"
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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.
- Conditions
- Cancer, Pancreas
- Being tested
- Oncothermia
- Keywords
- Pancreatic cancer, Quality of life, Pain
- Medical subject headings
- Pancreatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncothermiaOther
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
| Study group | Role | What they receive |
|---|---|---|
| Oncothermia group | Experimental | Patients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits. Receives: Other: Oncothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECOG score change
Measured: 3 months after oncothermia treatment
Secondary outcomes (1)
Progression free survival rate
Measured: 3 months later after oncothermia treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, PancreasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospicare Co., Ltd.
- Responsible party
- Principal investigator, Jin-Hyeok Hwang, Seoul National University Hospital
- Investigators
- Jin-Hyeok Hwang, MD PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150135
- Sponsor's protocol ID
- SNUBH-IMGPB-2014-02
- Status last verified
- Sep 2016
- First submitted
- 24 May 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT02150135
- Acronym / sponsor ID
- SNUBH-IMGPB-2014-02
- Conditions
- Cancer, Pancreas
- Keywords
- Pancreatic cancer, Quality of life, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hospicare Co., Ltd.
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncothermia group | Experimental | Other: OncothermiaPatients were treated with oncothermia 2 or 3 times a week. Treatment was performed for about 1 hours per each visits. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inoperable or recurred pancreatic ductal adenocarcinoma
- After the each cycle of chemotherapy, the disease status was "stable disease"
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncothermiaOncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia. | Other | Oncothermia group |
Primary outcome
ECOG score change
Time frame: 3 months after oncothermia treatment
1 secondary outcome
Progression free survival rate
Time frame: 3 months later after oncothermia treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Hyeok Hwang, MD PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oncothermia in people with Cancer, Pancreas, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECOG score change (time frame: 3 months after oncothermia treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.