Resiniferatoxin for Severe Cancer Pain

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

Recruiting Phase 1 Interventional Study
Intractable Pain Palliative Care
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR) · NIH
Who this trial is looking for

This trial is looking for adults with severe pain from advanced cancer that standard treatments cannot control. Participants will receive an experimental treatment through an injection into their spine while being monitored in the hospital for two days.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have advanced cancer that has not responded to standard treatments.
  • I experience severe pain related to my cancer.
  • My pain has not been controlled by alternative methods.
  • I am not seeking any curative treatments for my cancer.
  • I have the ability to complete the study procedures.
  • I can stop certain blood thinners for the study.
  • I have a responsible adult to help me if needed.

You may not be able to join if

  • I have pain coming from areas above the level of my chest.
  • I have a significant medical condition that could affect my safety.
  • I am pregnant or breastfeeding.
  • I have an allergy to chili peppers or capsaicin.
  • I have abnormal findings on my MRI that could complicate the procedure.
  • I have had unexplained fainting or severe heart issues.
  • I have had a seizure in the last month.
  • I have urinary or skin problems that haven’t improved.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transm…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA: Subject inclusion criteria are based on inadequate control of pain despite best efforts, including appropriate use of analgesic medications. To be enrolled in the study, subjects must meet all of the following criteria: 1. Age 18 years or older. 2. Clinical and histological d…
Contacts

John D Heiss, M.D.

Not Listed

SNBrecruiting@nih.gov

CONTACT