Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain

Starting soon · Phase 1/Phase 2

Conditions studied: Intractable Pain, Palliative Care

In brief

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. ...

Key facts

Study ID: NCT02522611
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 30
Starts: 2026-08-27
Expected to finish: 2026-12-01
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Subjects will be excluded from the study if they meet any of the following criteria:
Subject must not have primary pain source from anatomical regions at T5 dermatome or above.
Subject must not have pain due to causes other than cancer or its treatment that is moderate to severe in intensity.
Subjects must not be undergoing or have plans to undergo any active treatment for their cancer during the study until after the day 14 assessment timepoint, after the RTX injection.
Subject must not be anticipating initiation of palliative anti-tumor therapy or significant changes to current palliative anti-tumor therapy before completion of the Day 14 visit.
Subject must not have an ECG abnormality of which the baseline QTc interval exceeds 450 milliseconds.
Subjects must not have an allergy or hypersensitivity to chili peppers, capsaicin or radiographic contrast agents.
Subject must not have an anatomic abnormality or pathology of the spinal cord and/or PG space on magnetic resonance imaging (MRI) that could increase the risk of adverse effects of placement of the needle.
Subject must not have a contraindication to MRI or MRI contrast..
Subjects must not have evidence of a coagulopathy or hemostasis problem as
evidenced by the following blood laboratory values within the week prior to the planned injection:
PT/INR (prothrombin time/International normalized ratio) > 1.5 times upper limit of normal range (ULN).
PTT (partial thromboplastin time) > 35 seconds.
Subjects must not have a platelet count <50,000/mm3. Platelets will be transfused as necessary to raise the platelet count to greater than or equal to 100,000/mm3 prior to dosing.
Subjects must not have a total neutrophil count (TNC) <1500. The US Clinical Practice Guideline for lumbar puncture is a platelet count of 50,0000, which is higher risk for hemorrhage than periganglionic infection. Patients with TNC<1500 (neutropenia) may be eligible later if their TNC level becomes greater than 1500 spontaneously or after use of medications stimulating granulocyte production, such as Neupogen (granulocyte colony stimulating factor: G-CSF).
Subjects must not have abnormal electrolyte levels (i.e. low potassium) that cannot be corrected.
Subjects must not be febrile or have other evidence of an infection within 7 days of the planned periganglionic injection.
Subjects must not have an allergy or hypersensitivity to chili peppers, capsaicin, or radiographic contrast agents.
Female subjects must not be pregnant or breastfeeding.
Subjects with any medical condition that, in the Investigator s opinion, could adversely impact the subject s participation or safety, conduct of the study, or interfere with the pain assessment, such as poorly controlled diabetes or hypertension. Patients can be re-assessed for eligibility if these conditions can be controlled medically.
Subjects may not have a history of heart failure or unexplained fainting (syncope).
Subjects may not have a known family history of long QT syndrome.
Subjects who participated in a clinical trial of an investigational drug or device within 30 days of screening visit or are scheduled to receive an investigational product within 14 days of RTX injection.
Subjects must not have received invasive treatments, such as a neurolytic procedure, including surgical neurolysis, percutaneous regional or neuraxial continuous infusions (whether opioid or local anesthetic), peripheral neuromodulation or spinal cord stimulation.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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