Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
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|ClinicalTrials.gov Identifier: NCT02522611|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2015
Last Update Posted : August 6, 2020
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.
To learn whether RTX is safe and can reduce cancer induced bone pain.
People ages 18 and older with CIBP that is not relieved by standard treatments
Participants will have up to 6 outpatient visits over about 7 months. These will include:
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Intractable Pain Palliative Care||Drug: Resiniferatoxin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 1b Safety and Efficacy Trial of Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-Induced Bone Pain|
|Study Start Date :||August 12, 2015|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Schedule a maximum of 3 periganglionic DRG injection(s) at contiguous level(s) to treat targetedDRG responsible for chronic CIBP
Resiniferatoxin (RTX) is an ultrapotent agonist analog of capsaicin that targets a receptor expressed on specific dorsal root sensory ganglia (DRG) neurons and is expected to reduce pain within the targeted zone.
- Maximum tolerated dose (MTD) [ Time Frame: Completion of study ]MTD will be defined as 1 dose level below that at which dose-limiting toxicity (DLT) is observed in more than one third of the subjects.
- Safety/toxicity profile [ Time Frame: Completion of study ]The Investigator will assess the AE for severity and relationship of the AE to RTX or the injection (causality determination of the AE toeither the RTX or the injection procedure itself).
- Identify dose-limiting toxicities (DLT) [ Time Frame: Completion of study ]DLT is defined as the development in a subject of a CTCAE grade 3 or higher agent-related toxicity or two or more grade 2 agentrelatedtoxicities occurring in the same subject at any time from dosing through the D14 visit.
- Improved pain relief through the 180-day time point compared to baseline [ Time Frame: Completion of study ]The average of the daily worst NRS scores will be used throughout the study for post-injection visits.
- Substantially reduced (20%) pain at the 30-, 60-. 90-, and 180-day post-treatment time points compared to the pain experienced at baseline [ Time Frame: Completion of study ]The average of the daily worst NRS scores will be used throughout the study for post-injection visits.
- Substantially reduced (20%) concomitant opioid analgesic consumption [ Time Frame: Completion of study ]The average of the daily worst NRS scores will be used throughout the study for post-injection visits.
- Improved quality of life [ Time Frame: Completion of study ]The BPI is a validated tool designed to assess the severity of pain and the impact of pain on daily functions in patients with cancer pain and pain due to other chronic diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522611
|Contact: Tracy S Williams, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||John D Heiss, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|