Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Background:
Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to
anxiety, depression, and reduced mobility and quality of life. Researchers believe a research
drug called resiniferatoxin (RTX) may be able to help.
Objective:
To learn whether RTX is safe and can reduce cancer induced bone pain.
Eligibility:
People ages 18 and older with CIBP that is not relieved by standard treatments
Design:
Participants will have up to 6 outpatient visits over about 7 months. These will include:
Medical history
Physical exam
Blood and urine tests.
Thermal testing: a disk placed on the skin to test ability to sense temperature in and around
the area of pain
Chest x-ray
EKG: stickers are placed on the chest to measure heart signals
ECG: measures electrical activity of the heart
Participants will have 1 inpatient visit lasting 2-4 days. This will include:
Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray
contrast.
A needle is passed through the skin of the back to inject the RTX.
Participants will keep a log of the pain medications they take after surgery.
Participants will be called 1 week and 2, 3, and 4 months after the injection.
Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after
the injection.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)