Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02522611|
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : February 15, 2019
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 Neoplasm Metastasis Questionnaires &Amp; Surveys||Drug: Resiniferatoxin||Phase 1 Phase 2|
Show Detailed Description
|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 :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2020|
Patient receives one dose of Resiniferatoxin intrathecally
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.
- The primary outcome is to achieve a dose-response relationship for safety [ Time Frame: 30, 60, 90, and 180 days ]
- substantially reduced pain; improved pain relief; substantially reduced concomitant opioid analgesic consumption; improved quality of life [ Time Frame: 30, 60, 90, and 180 days ]
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: Fredric K Cantor, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|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 firstname.lastname@example.org|
|Principal Investigator:||John D Heiss, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|