TMS for the Treatment of Pancreatic Cancer Pain
The Effect of a 10-day Course of Transcranial Magnetic Stimulation on Abdominal Pain in Patients With Locally Advanced and Advanced Pancreatic Cancer, a Randomized Phase II Study.
2 other identifiers
interventional
3
1 country
1
Brief Summary
This is a phase II study that aims to investigate prospectively a new therapy for a cohort of patients with chronic pain attributed to pancreatic cancer. The justification of this study is that the pain is the most important factor for the quality of life of these patients and rTMS has been shown to be significantly associated with pain improvement in patients with abdominal pain due to chronic pancreatitis. This therapeutic trial will be a 10-day, randomized, parallel-group design, double-blind, incomplete cross-over, placebo controlled clinical trial conducted at Beth Israel Deaconess Medical Center. The principal aim of this investigation is the study of pain after a therapeutic intervention. The primary outcome is pain reduction indexed by pain reduction and or analgesic intake reduction. The second aim of the study is to assess the safety this new treatment in patients with pancreatic cancer. The third aim of this study is to investigate whether rTMS treatment is associated with a change in the activity of right secondary somatosensory cortex using magnetic resonance spectroscopy. Because patients with locally advanced or advanced pancreatic cancer often require increasing doses of narcotic pain medications, such as morphine, oxycodone and fentanyl, in order to control their pain, adverse side effects are frequent observed in this population of patients. Therefore rTMS treatment might represent a new therapeutic approach that might be useful not only for pancreatic cancer but also to other types of cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started May 2006
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 10, 2006
CompletedFirst Posted
Study publicly available on registry
May 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMarch 21, 2017
March 1, 2017
5.5 years
May 10, 2006
March 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain (visual analog scale, CGI,PGA); Medication use (medication diary)
1 year
Secondary Outcomes (1)
Safety (cognitive assessment - neuropsychological battery)
1 year
Study Arms (2)
Transcranial Magnetic Stimulation (TMS)
EXPERIMENTALThis arm provides active 1Hz repetitive TMS (rTMS) applied to SII
Transcranial Magnetic Stimulation Sham
SHAM COMPARATORThis arm provides sham 1Hz repetitive TMS (rTMS) applied to SII
Interventions
1Hz repetitive transcranial magnetic stimulation for 10 days 26 minutes each day
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic pancreatic cancer
- Abdominal pain attributable to pancreatic cancer that requires daily narcotic use
- Stable narcotic dosage the week before study entry
- A computed tomography of the abdomen within four weeks of study entry
- CA19-9 within four weeks of study entry
- ECOG Performance status \>=3
You may not qualify if:
- Known brain metastasis
- Patients with major depression with suicidal risk
- Prior neurosurgical procedures
- History of epilepsy
- Previous head injury
- History of Stroke
- Abnormal neurological examination other than as signs of the condition studied in the present protocol
- Contraindication to TMS:
- Implanted pacemaker;Medication pump;Vagal stimulator;Deep brain stimulator;Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding;Signs of increased intracranial pressure
- TENS unit and ventriculo-peritoneal shunt
- Pregnancy
- Unable to undergo a brain MR
- claustrophobia refractory to anxiolytics
- ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD, PhD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2006
First Posted
May 11, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 21, 2017
Record last verified: 2017-03