Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
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.
Timeline
- Start
- 2026-06-27
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
Publications
- Background Mannes AJ, Brown DC, Keller J, Cordes L, Eckenhoff RG, Caudle RM, Iadarola MJ, Meng QC. Measurement of resiniferatoxin in serum samples by high-performance liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Sep 5;823(2):184-8. doi: 10.1016/j.jchromb.2005.06.042.
- Background Neubert JK, Mannes AJ, Karai LJ, Jenkins AC, Zawatski L, Abu-Asab M, Iadarola MJ. Perineural resiniferatoxin selectively inhibits inflammatory hyperalgesia. Mol Pain. 2008 Jan 16;4:3. doi: 10.1186/1744-8069-4-3.
- Background Iadarola MJ, Mannes AJ. The vanilloid agonist resiniferatoxin for interventional-based pain control. Curr Top Med Chem. 2011;11(17):2171-9. doi: 10.2174/156802611796904942.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resiniferatoxin | Other / unclassified | 0.8 ug | Other |
| Subject | Resiniferatoxin | Other / unclassified | 1.6 ug | Other |
| Subject | Resiniferatoxin | Other / unclassified | 3.2 ug | Other |
| Subject | Resiniferatoxin | Other / unclassified | 6.4 ug | Other |
Indications
No indication recorded.