TMS for the Treatment of Pancreatic Cancer Pain
Recruitment status was Active, not recruiting
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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 | Phase |
|---|---|---|
|
Pain Visceral Pain Pancreatic Cancer |
Procedure: Transcranial Magnetic Stimulation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label 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. |
- Pain (visual analog scale, CGI,PGA); Medication use (medication diary) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Safety (cognitive assessment - neuropsychological battery) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 32 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | February 2008 |
| Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I |
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 |
| Genders Eligible for Study: | Both |
| 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| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Felipe Fregni, MD, PhD | Beth Israel Deaconess Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Felipe Fregni, MD, Beth Israel Deaconess Medical Ceter |
| ClinicalTrials.gov Identifier: | NCT00324428 History of Changes |
| Other Study ID Numbers: | 2005P-000311, R03DK071851 |
| Study First Received: | May 10, 2006 |
| Last Updated: | February 3, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by 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 Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013