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TMS for the Treatment of Pancreatic Cancer Pain

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ClinicalTrials.gov Identifier: NCT00324428
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pain Visceral Pain Pancreatic Cancer Procedure: Transcranial Magnetic Stimulation

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : May 2006
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Transcranial Magnetic Stimulation (TMS)
This arm provides active 1Hz repetitive TMS (rTMS) applied to SII
Procedure: Transcranial Magnetic Stimulation
1Hz repetitive transcranial magnetic stimulation for 10 days 26 minutes each day
Sham Comparator: Transcranial Magnetic Stimulation Sham
This arm provides sham 1Hz repetitive TMS (rTMS) applied to SII
Procedure: Transcranial Magnetic Stimulation
1Hz repetitive transcranial magnetic stimulation for 10 days 26 minutes each day

Outcome Measures

Primary Outcome Measures :
  1. Pain (visual analog scale, CGI,PGA); Medication use (medication diary) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Safety (cognitive assessment - neuropsychological battery) [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324428

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Felipe Fregni, MD, PhD Beth Israel Deaconess Medical Center
More Information

Additional Information:
Responsible Party: Felipe Fregni, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00324428     History of Changes
Other Study ID Numbers: 2005P000311
R03DK071851 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Felipe Fregni, Beth Israel Deaconess Medical Center:
Visceral Pain
Pancreatic Cancer
Electric stimulation therapy
Electric stimulation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Visceral Pain
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Nociceptive Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms