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TMS for the Treatment of Pancreatic Cancer Pain

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Felipe Fregni, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00324428
First received: May 10, 2006
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
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 Intervention
Pain Visceral Pain Pancreatic Cancer Procedure: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Felipe Fregni, Beth Israel Deaconess Medical Center:

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

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

Enrollment: 3
Actual Study Start Date: May 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324428

Locations
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)
Investigators
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 ( US NIH Grant/Contract Award Number )
Study First Received: May 10, 2006
Last Updated: March 17, 2017

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

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

ClinicalTrials.gov processed this record on June 22, 2017