The purpose of this research study is to investigate the safety and effectiveness of a new treatment for unmanageable pain in patients with advanced cancer.
Description of study:
- In this study, the research drug will be injected directly into the fluid surrounding the spinal cord. This is the first trial in humans where this drug is injected into the spinal fluid.
- Studies in animals have shown pain relief after the spinal administration of this treatment.
- The study involves up to eight visits to the National Institutes of Health Clinical Center in Bethesda, Maryland. There will be one inpatient visit that will last two to three days; the rest will be outpatient visits lasting four to six hours. There will be a screening visit, a treatment visit and four follow-up visits, which occur beginning seven days after treatment. The participant will also be followed by telephone for approximately seven months after the treatment visit.
You may qualify if:
- You have a diagnosis of advanced cancer.
- You are age 18 or older.
- You are unable to relieve your pain with medication.
- The pain you are experiencing is at or below the level of your chest.
You may not qualify if:
- Your pain is not caused by cancer.
- You cannot have a MRI (magnetic resonance imaging) scan.
- You have allergies to chili peppers or capsaicin (e.g., causing hives).
- You are pregnant.
There is no charge for study-related tests.
Travel costs may be reimbursed.
For more information, please call toll free:
1-800-411-1222
TTY: 1-866-411-1010
Se habla español
Or go online:
clinicaltrials.gov
Refer to study #09-D-0039
Department of Health and Human Services
National Institutes of Health
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